Centralized Study Associate Ii

6 months ago

Bengaluru Karnataka, India Fortrea Full time

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Summary of Responsibilities:

- To complete Other duties/activities as assigned by study management team, but not limited to:

- Manage clinical systems & access management
- Maintain study databases (CTMS, IWRS, EDC etc.)
- Support study team in e-TMF management activities Ø Support study team in data review and support activities.
- Support in generating the study specific reports.

Data Review:
o 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.
- And all other duties as needed or assigned

Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our

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