Centralized Study Analyst

Fortrea

Location: Bengaluru, Karnataka, India
Job type: Full-time

Required skills

compliance
GCP
technical support

About the role

Fortrea

Website: fortrea.com
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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