Summary of Responsibilities:
- To complete Other duties/activities as assigned by study management team, but not limited to:
- Manage clinical systems and access management.
- Maintain study databases (CTMS, IWRS, EDC, etc.)
- Support study team in e-TMF management activities.
- Support study team in data review and support activities.
- Support in generating the study specific reports.
- 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.
- Study Support:
- Generate Study Reports.
- 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 approval.
- Process Out of Pocket and Pass Through Expense Invoices.
- Perform payment reconciliation during the study close out or on adhoc 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 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.
- To assist the study, startup teams with tasks required for site start up activities.
- To manage and support assigned studies for upload as per set objectives.
- To follow up with study team on uploading queries.
- 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.
- Create i Site Pack
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).
- 02-03 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.
- Fluent in English, both written and verbal.
Experience (Minimum Required):
- 02-03 Years of experience in the job discipline.
- 00-03 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.
Learn more about our EEO & Accommodations request here.
