Careers

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Careers

Our commitment to customer satisfaction is what drives our dedication to finding individuals who are highly motivated, creative, skilled, open, and honest. When searching for the right people, both cultural fit and work experience are very important to us. Our insistence on the right people helps keep us at the forefront of our industry. At ResearchPoint Global, you will find experienced leadership that encourages participation in every step of clinical development.

Our people are our most important asset because how well we develop our team is a direct reflection on how well we are perceived in the marketplace

–John Farinacci, CEO and Founder, ResearchPoint Global

We are not only looking for proven skill sets, but also for candidates that fit well within our culture. To apply for one of the positions below, please follow the instructions as indicated.

 

Senior Manager, Proposals & Contracts

ResearchPoint works hard at maintaining an open communications style and environment. As a successful and growing CRO we actively seek your participation in the company’s growth and development.

The result: A great team of people who care about the work they do and the people they work with. We seek people who will make a difference in our business every day.

Job Summary: The Senior Manager, Proposals & Contracts works independently to ensure proposal deadlines are met with submittal of professional, detailed, and quality proposal text and study budgets.  We strongly prefer this as an in-office position.

 

Essential Job Functions:

  • Provides operational support for Business Development
  • Coordinate proposal teams, including clinical, data, and medical monitoring teams as well as all required vendors in writing text for RPG proposals, including:
    • Develop proposal schedules and lead proposal teams to timely submittals of proposals input
    • Write proposal strategies, risk mitigations, and standard project approach text
    • Tailor experience summaries
    • Coordinate multiple review levels, including Executive review
    • Perform final formatting in Word/Excel
    • Maintain all electronic files/budgets/contract documents on file server to coincide with records in Finance Dept. and client submittals
  • Lead the study budget development process by working with Operational Leads, including clinical, data, and medical monitoring teams as well as all required third-party vendors. Including:
    • Develop draft budgets and strategize with clinical and data team to make the study-specific adjustments to standard pricing, and finalize for corporate review
    • Participate in regular budget tool adjustments and maintain budget files accordingly
  • Upon contract award, serve as BD Department Point of Contact for Finance Dept. and Project Managers for all contract related study matters
  • Coordinate and run Project Transition Meetings (aka, “Handoff” from BD to Operations upon award)
  • Develop and maintain all study related budgets and contract documents, including Master Service Agreements, Work Orders, and Contract Change Orders
  • Assist with Proposal Defense Meeting slide coordination/content
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
  • Works under close supervision from supervisor or senior personnel.
  • Ability to work in a team environment and independently as required
  • May be required to work Holidays and weekends
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
  • Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
  • Other duties as assigned
  • May be required to assist in other departments

 

Job Requirements

 

Experience / Education:         

  • 5 years of relevant experience or equivalent
  • Bachelor’s Degree or equivalent experience)

 

Knowledge / Skills / Abilities: 

  • Must have excellent organization skills, writing, communication, and budgeting skills (proficient in MS Office)
  • Must be able to thrive in stressful, deadline-driven environment with multiple priorities
  • Highly independent, self-starter with an ability to take input from all levels of the BD and Operations teams to create clear and effective proposals
  • Need to be able to read, write and understand English

 

Physical Requirements:                  

  • Must be able to work in an office environment, which has minimal noise conditions
  • Ability to stand or sit for most of the work day
  • Must be able to perform some activities with repetitive motion, such as keyboarding

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

Apply via

https://careers-wuxiapptec.icims.com/jobs/3897/senior-manager%2c-proposals-%26-contracts/job

Job Type: Full-time

Job Location:

Austin, TX or Remote Potential

 

Send inquiries to careers@researchpoint.com

Bilingual (Mandarin) Senior Programmer

Description:

ResearchPoint works hard at maintaining an open communications style and environment. As a successful and growing CRO we actively seek your participation in the company’s growth and development.

The result: A great team of people who care about the work they do and the people they work with. We seek people who will make a difference in our business every day.

Qualifications:

Perform a variety of project programming tasks including but not limited to gathering requirements and specifications, annotation of case report forms, create test and validation plans, and creation and maintenance of other documentation in support of programming.

Creates and validates SAS code to produce/generate statistical tables and listings. Supports database management system creation and validation. Designs and sets up database objects, data entry screen layouts, and appropriate views within the application according to the study protocol.  Develops and implements error checking programs and data validation routines to ensure the integrity of the clinical databases.

Assist in standardization efforts and in developing documentation for data management system implementation and for user training.

Willing and capable of coaching/mentoring junior Programmers and assists with supporting the vision of the department

Requirements:

Bachelor’s Degree in Computer Science, related field, or the equivalent experience. 5+ years of clinical programming including 3+ years within a data management or biostatistics department.

Bi-lingual Mandarin Chinese preferred.  Requires good oral and written communication skills to interact with clients and other members of project team, including vendors and to build rapport with each.  Ability to effectively communicate issues and potential resolutions to other team members, project manager, and supervisor. Must show excellent interpersonal communication skills.

Must exhibit positive, professional demeanor in all communications with other employees, management, sponsors and other outside personnel.  Must exhibit concise technical writing skills with minimal grammatical or logical errors.

Requires a minimum of 5 years of programming including 3+ years in data management or biostatistics department. SAS, SQL, and other relational databases (MS Access, etc) programming within a Clinical Trials Database. Experience in Report development. Must be familiar with data management and statistical industry standards and GCPs.

Knowledge of formal database concepts and relational database design experience. Experience in software coding, documenting, debugging, testing, validating, implementation, and maintenance. Working knowledge of Windows systems. Familiarity with Microsoft office products including Word, Excel, and Access. Strong verbal and written communication skills.  Must have ability to initiate steps according to established processes without intervention.  Must have ability to interact with internal and external customers and sites professionally, using clear diction. Must be able to solve problems independently or through consultation with more programmers, supervisors or project manager when required and must be able to anticipate risks to the project within the scope of the position. Ability to organize workload and handle multiple priorities.  Ability to work in team environment and manage multiple priorities within established time constraints.  Expected to have knowledge of Good Clinical Practices and Good Clinical Programming Practices.

Apply via

https://careers-wuxibiologics.icims.com/jobs/3486/bilingual-sas-programmer/job?mode=view

Job Type: Full-time

Job Location:

Austin, TX (Remote Potential)

 

Send inquiries to careers@researchpoint.com

Senior Clinical Data Manager

ResearchPoint works hard at maintaining an open communications style and environment. As a successful and growing CRO we actively seek your participation in the company’s growth and development.

The result: A great team of people who care about the work they do and the people they work with. We seek people who will make a difference in our business every day.

Job Summary: The Senior Clinical Data Manager performs clinical database setup, maintenance, and data quality control functions through database lock in accordance with Good Clinical Practices (GCP), International Conference on Harmonisation (ICH), and ResearchPoint Global and Sponsor SOPs. This can be either an in-office or WFH position.

Essential Job Functions:

  • Provides operational support for Data Operations
  • Serves as data management lead interacting directly with sponsor, sites and vendors on complex paper-based or EDC projects under minimal supervision
  • Performs and is accountable for all data management activities such as data collection and entry, database access requirement implementation, project specific training, and/or other tasks associated with the clinical trial database
  • Manages processes to ensure data integrity via appropriate data management processes, such as manual data listing reviews, query review and generation for missing or discrepant data, evaluating data outliers, performing data or query quality checks, ensuring database updates are applied, etc.) in accordance with approved study documentation
  • Functions as the primary contact for sites or other study team members if there are questions regarding data management issues for their assigned trial
  • Proactively performs data management study startup activities including CRF/eCRF design, CRF annotation, developing database specifications, and defining validation specifications, and database and validation specification testing
  • Participates in internal/sponsor meetings and training programs, as required, working directly with the assigned project manager to provide data management support
  • May lead such meetings and provide formal training as required
  • Performs Business Development functions including but not limited to attendance and participation in client meetings
  • Performs data management study close-out activities including finalizing SAE reconciliation, medical coding, and quality control steps in accordance with RPG Standard Operating Procedures
  • Ensures approved study documentation is maintained and properly stored in the trial master files
  • Supports other team members and provides leadership in this function as needed
  • Manages project resources according to budget and notifies project manager and supervisor of any potential out-of-scope requests from clients
  • Notifies project manager and/or supervisor of any potential out-of-scope requests or work issues that will affect project budget or timelines
  • Assists with training and mentoring of study team members on the DM project specific tasks
  • Assists with training employees on departmental procedures and processes and technical tasks
  • Works under close supervision from supervisor or senior personnel
  • Ability to work in a team environment and independently as required
  • May be required to work Holidays and weekends on rare occasions
  • Contributes to the overall operations and to the achievement of departmental goals
  • Other duties as assigned
  • May be required to assist in other departments

Job Requirements

 

Experience / Education:         

  • 5- Associates degree with minimum 5 years DM lead experience; or the equivalent industry work experience (5-7 years)BS or MS in Life Sciences or technical degree with 4 years DM lead experience is preferred

Knowledge / Skills / Abilities: 

  • Must be able to utilize experience and knowledge to make logical and appropriate decisions on a wide range of data management projects and tasks with little or no guidance or supervision
  • Can be depended upon for reliability and judgment. Has respect of peers, sponsors and management
  • Produces quality services and is accountable for project success
  • Must be able to review data management documents and files in advance of Quality Assurance review with high level of accuracy
  • Makes decisions on the quality of the documents and take appropriate action
  • Must make effective decisions on managing tasks within time constraints so that deadlines are not missed
  • Expected to require minimal supervision on issues that can have substantial impact on clinical and data quality issues
  • Requires excellent oral and written communication skills to interact with investigative sites, sponsors and vendors and to build rapport with each
  • Ability to effectively communicate issues and potential resolutions to sites, other team members, project manager, and supervisor
  • Must show excellent interpersonal skills
  • Is comfortable creating & making presentations before clients or prospective clients
  • Must exhibit concise technical writing skills in English with minimal grammatical or logical errors
  • Need to be able to read, write and understand English (bilingual in Mandarin preferred)
  • Must have extensive experience with DM start up, maintenance and closeout activities in both paper and EDC studies
  • Ability to demonstrate knowledge of Good Clinical Practices (GCP), and International Conference on Harmonisation (ICH)
  • Experience in moderate to complex projects, paper based and EDC Databases. Some global project experience preferredExperience with projecting budgets for proposed projects and making capabilities & bid defense presentations
  • Must have experience in managing clinical trial databases in Pharmaceutical or related industry including global projects a plus (experience with both paper-based and EDC studies preferred)
  • Familiarity with SAS including basic programming skills a plus
  • Advanced skills with Microsoft Office Suite applications; must have strong attention to detail and demonstrate understanding of the critical nature of ResearchPoint Global documentation
  • Must be able to solve problems independently when required and must be able to anticipate and judge risks to the project and to implement or to propose solutions to supervisor when required
  • Must have positive, professional demeanor with all interactions on the phone or in the office
  • Must have ability to effectively deal with complex client interactions
  • Ability to organize workload and handle multiple priorities
  • Ability to work in team environment and effectively manage multiple priorities within established time constraints
  • Ability to mentor staff
  • Expected to have good working knowledge of Good Clinical Practices and Good Clinical Data Management Practices
  • Travel is required 5%, primarily domestic/infrequently international, daily/overnight; if driving, must have valid driver’s license and be able to rent a car.

Physical Requirements:                  

  • Must be able to work in an office environment, which has minimal noise conditions
  • Ability to stand or sit for most of the work day
  • Must be able to perform some activities with repetitive motion, such as keyboarding
  • If working remote: must be able to travel for long distances in various methods of transportation (e.g. car, airplane, shuttle bus, train, etc.) on an infrequent basis
  • Must be able to navigate to and from site locations, hotel, and airports with personal luggage and laptop when traveling

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

Apply via

https://careers-wuxiapptec.icims.com/jobs/3775/senior-clinical-data-manager/job?mode=view

Job Type: Full-time

Job Location:

Austin, TX (Remote Potential)

 

Send inquiries to careers@researchpoint.com

Project Specialist I

ResearchPoint works hard at maintaining an open communications style and environment. As a successful and growing CRO we actively seek your participation in the company’s growth and development.

The result: A great team of people who care about the work they do and the people they work with. We seek people who will make a difference in our business every day.

Job Summary: The Project Specialist I supports project managers to ensure the contracted services and expectations of clinical studies are carried out by project teams in accordance with the executed contracts and the customer expectations. This is in-office position with <10% travel required.

Essential Job Functions:

  • Provides operational support for Clinical Operations
  • Establishes tracking procedures for projects under minimal direction of manager; maintains and updates project tracking tools, metrics, and computer databases, and meeting minutes as required
  • Conducts secondary review of essential regulatory documents
  • May serve as project representative for internal and external TMF audits

May serve as primary site contact for collection of regulatory documents, tracking and maintaining drug/study supplies, and administrative study related questions

  • Provides indirect management and direct training of Research Associates
  • Performs quality reviews under the direction of the project manager as required including, but not limited to, review of trial and site study files
  • Assists with communication and leadership within the Clinical Operations team and may serve as designated point person in absence of Manager, Clinical Administration and/or Project Manager
  • Performs training within the company
  • High-quality and timely deliverables, and minimal quality errors
  • Position has no direct budget responsibilities, but inadequate quality of work may result in missed deadlines including contract bonuses and penalties
  • Gives indirect management/guidance to RAIs and RAIIs and direct training on project-specific tasks
  • Receives supervision from Manager, Clinical Administration, Project Specialist II, Project Manager, or other operational staff providing leadership on operational projects
  • Ability to work in a team environment and independently as required
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
  • Demonstrates flexible and efficient time management, ability to prioritize workload, exercise good judgment in a variety of situations and work under pressure at times to handle a wide variety of activities and confidential matters with discretion

Job Requirements

Experience / Education:          

 Minimum of 3 years in clinical research environment managing administrative aspects of clinical trials or equivalent experience; previous supervisory experience and company experience preferred

  • High School diploma or associate’s degree required
  • Bachelor’s degree preferred

 

Knowledge / Skills / Abilities: 

  • Demonstrates problem solving ability, taking into consideration time, quality, and customer relations
  • Independently extrapolates and applies decisions from previous discussions to new situations and recognizes the relevance from one situation to the next
  • Requires only minimal supervision on decisions that could have substantial impact on clinical administration issues
  • Must show ability to review regulatory documents in advance of quality assurance review with high level of accuracy and make decisions on the quality of the documents and take appropriate action
  • Requires good oral and written communication skills to interact with other members of project team and to build rapport with sites and others as needed
  • Ability to effectively communicate issues and potential resolutions to sites, CRAs, and manager
  • Must show excellent interpersonal communication skills and exhibit ability to build rapport with team members
  • Ability to teach and effectively communicate to other clinical administration staff
  • Must exhibit good technical writing skills in English with minimal grammatical or logical errors
  • Exceptional communication and professional rapport with internal and external customers, setting the example for others and mentoring team members as needed
  • Intermediate to advanced skills with Microsoft Office Suite applications
  • Must have strong attention to detail and demonstrate understanding of the critical nature of RPG documentation
  • Must have ability to initiate steps according to established processes without intervention
  • Must have ability to interact with internal and external customers professionally, using clear diction
  • Must be able to solve problems independently and must be able to anticipate risks to the project within the scope of the position and to propose solutions
  • Must have positive, professional demeanor with all interactions on the phone or in the office
  • Ability to organize workload and handle multiple priorities, as well as manage and train other Clinical Administration staff on best practices and how to manage their time and schedules
  • Ability to work in team environment
  • Must have high level of adaptability as task requirement and priorities change quickly

 

Physical Requirements:                   

  • Must be able to work in an office environment, which has minimal noise conditions
  • Ability to stand or sit for most of the work day
  • Must be able to perform some activities with repetitive motion, such as keyboarding
  • <10% travel required

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

Apply via

https://careers-wuxiapptec.icims.com/jobs/4015/project-specialist-i/job?mode=view

Job Type: Full-time

Job Location:

Austin, TX (Remote Potential)

 

Send inquiries to careers@researchpoint.com

Research Associate I

Apply via: https://careers-wuxiapptec.icims.com/jobs/4038/research-associate-i/job?mode=view

ResearchPoint works hard at maintaining an open communications style and environment. As a successful and growing CRO we actively seek your participation in the company’s growth and development.

The result: A great team of people who care about the work they do and the people they work with. We seek people who will make a difference in our business every day.

Job Summary: The Research Associate I provides administrative support to clinical research projects by assisting project teams in the completion of assigned project activities. This is an in-office position with that does not require travel.

 

Essential Job Functions:

  • Provides operational support for Clinical Operations
  • Under direct supervision prepares, reviews and distributes the regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan
  • Under direct supervision prepares the investigator regulatory binders and other study start-up materials, following established procedures
  • Under direct supervision designated Clinical Trial Management System (CTMS) to track and process clinical trial information, (e.g., site lists/personnel, regulatory documents, Institutional Review Board re-approvals) in order to provide analysis of information to PM
  • Prepares and provides status reports to customers with oversight from assigned PM
  • Under direct supervision assures the maintenance of the TMF
  • Under direct supervision attends clinical staff meetings, project team meetings, and clinical training sessions according to project management, and generates meeting minutes as directed
  • Under direct supervision prepares, reviews, and distributes regulatory packets, investigator regulatory binders and other study start-up materials under supervision
  • Under direct supervision performs additional administrative functions including but not limited to data entry, phone coverage, photocopying, word processing
  • Minimal quality control errors with data entry or filing
  • Timely receipt of deliverables
  • Receives supervision from line manager, project manager, or other operational staff providing leadership on operational projects
  • Must show ability to present solutions to issues; must show ability to apply previous lessons to future project work
  • Is expected to seek direction for all issues requiring a decision
  • Serve as the host for sponsor visits and audits
  • Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required
  • Ability to work in a team environment and independently as required
  • May be required to work Holidays and weekends
  • May be required to work Overtime
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures
  • Thorough understanding of FDA Guidelines, ICH, GCP, NDA, IND and other applicable regulations
  • Other duties as assigned
  • May be required to assist in other departments

 

Job Requirements

 

Experience / Education:          

  • 1 year in office administration or equivalent with preference given to clinic or hospital environment
  • HS diploma required, Associate’s Degree preferred
  • Certification in medical transcription, office management preferred

 

Knowledge / Skills / Abilities:

  • Must show good interpersonal communication skills in English
  • Must exhibit positive, professional demeanor in all communications
  • Basic MS Office Skills
  • Effective time management and organizational skills
  • Travel is not required

 

Physical Requirements:                   

  • Must be able to work in an office environment, which has minimal noise conditions
  • Ability to stand or sit for most of the work day
  • Must be able to perform some activities with repetitive motion, such as keyboarding

 

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.

 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

 

Apply via

https://careers-wuxiapptec.icims.com/jobs/4038/research-associate-i/job?mode=view

Job Type: Full-time

Job Location:

Austin, TX

 

Send inquiries to careers@researchpoint.com

ResearchPoint Global is an Equal Opportunity Employer. ResearchPoint Global does not discriminate against any employee or applicant on the basis of age, gender, sexual orientation, race, religion, nationality, ethnicity, veteran status, the presence of disability, or other legally protected status.