Fortrea
Website:
fortrea.com
Company:
https://www.linkedin.com/company/fortrea
Seniority: Not Applicable
Industries: Biotechnology Research
Job details:
Summary Of Responsibilities
- To complete other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems and access management.
- Manage study documents and support eTMF management.
- Maintain study databases (CTMS, IWRS, EDC, etc.)
- Support study team in data review and support activities.
- Track and follow up with CRAs for outstanding issues.
- Support in generating the study specific reports.
- Manage internal/external communications.
- Assist in ensuring training compliance for study teams.
- Manage study payments (Site and Vendor).
- Data Review:
- Follow up with CRA for resolution of the outstanding issues/action items related to assigned tasks.
- Assist the Lead for any study specific data review related tasks.
- Draft and send study specific reports as per the study team instructions.
- Perform any other data review related tasks as per the project team instructions.
- Document Review:
- Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial.
- Review amended Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- File amended Informed Consent Form and Investigator Package approval documentation in TMF and eTMF.
- Review Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight.
- Study Support:
- Generate Study Reports and perform analysis.
- Perform Access management on applicable study systems.
- Perform study system set up on new awarded studies.
- CTMS compliance management.
- Manage project communications.
- Assist project teams for other study support activities.
- Investigator Payments:
- Review EDC, Contract, and mark line items “Ready to Pay/Screen Failure” in CTMS.
- Work with PA to generate cover letter or Proforma invoice and payment batch generation in CTMS.
- Perform Invoice QC and Prepare GIA as applicable.
- Coordinate with CTL, PM for line-item approvals and GIA approvals.
- Process Out of Pocket and Pass-Through Expense Invoices.
- Perform payment reconciliation during the study close out or on ad hoc request by the study team.
- To follow all applicable departmental Standard Operating Procedures and Work Instructions:
- To complete required trainings according to required timelines.
- To complete day-to-day tasks ensuring quality and productivity.
- To manage project and technical documentation in an appropriate manner.
- To provide administrative and technical support to internal departments and teams as needed.
- To perform checks to ensure quality of work completed.
- To ensure timely escalation and issue resolution as needed.
- To track and report metrics as determined by management according to required timelines.
- To participate in process improvement opportunities and assist with the implementation of revised processes and procedures.
- To assist in the document management (including document template creation, collection, review, processing and tracking up to eTMF filing) for all documents in the scope of agreed processes/activities or within the scope of GSDM throughout the study duration.
- To assist in the preparation of new investigator submission packages for site/regulatory submission.
- To assist in Investigator Payment Processing, Site budget validation and related activities.
- To assist the study start up teams with tasks required for site start up activities.
- To review, Support, Manage or assist in Managing the site clinical trial contracts in accordance with defined processes and timelines.
- All other duties as needed or assigned.
Qualifications (Minimum Required)
- University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate accredited institution (Ex. Nursing certification, Medical or laboratory technology).
- 03-05 years of work experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other applicable guidelines and regulations.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required)
- 03-05 Years of experience in the job discipline.
- 00-02 Years of experience in other professional roles.
- Other required work-related experiences:
- Demonstrated ability to organize and communicate effectively.
- Demonstrated ability to pay attention to detail.
- Ability to work well with others.
- Ability to deliver consistent high quality of work.
- Ability to use computer and departmental tools.
Physical Demands/Work Environment
- General Office Environment.
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