Team Lead & QA - Ruby Hall Clinic - Bund Garden, Pune
(2023-01)
Currently working as Team Lead and Quality Check.
- Reviewed completed work to verify consistency, quality, and conformance.
- Managed daily operations to ensure team alignment with trial goals.
- Facilitated team meetings to encourage collaboration and problem-solving initiatives.
- Managed daily workflow of team members to meet organizational goals
- Ensure timely documentation of all source notes as per ALCOA Principle.
- Conducting regular internal reviews of the clinical trial participant files.
- Conducting regular internal reviews of the ISF to identify missing or expired documents.
- Ensure all timely entered data entries and query resolution.
- Ensure all SAEs are notified within stipulated timeframe.
- Support the recruitment process to select appropriate candidates to meet business needs.
- Ensured compliance with company regulations, laws, and safety standards.
- Promote quality improvements and recommendations
- Conducted regular performance reviews with direct reports.
Senior Clinical Research Co-ordinator - Ruby Hall Clinic - Bund Garden, Pune
(2016-01 - 2022-12)
Clinical Research Coordinator - Ruby Hall Clinic - Bund Garden, Pune
(2012-10 - 2016-12)
Roles and Responsibilities as Clinical Research Coordinator include Study Start-Up (Pre-Trial), Ethics Committee (EC) Submission, Site Readiness for Site Selection Visit (SSV), Site Readiness for Site Initiation Visit (SIV), During Study Conduct, and During Study Close-Out (Post-Trial).
- Feasibility Questionnaire (FQ) & Confidentiality (CDA) - Responsible for gathering the data necessary to prove the site can successfully run the trial.
- CDA Management: Facilitate the review and signing of the Confidentiality Disclosure Agreement (CDA) between the PI and the sponsor to receive the study protocol.
- Data Collection: Collect information from the PI regarding their experience and the available patient population.
- Questionnaire Completion: Complete the FQ by detailing site infrastructure (e.g., storage, equipment), staff qualifications, and recruitment potential.
- Timely Submission: Ensure the completed FQ and any required supporting documents are sent back to the sponsor/CRO promptly to remain in consideration.
- Manages the regulatory path to ensure the study is approved before any participants are enrolled.
- Document Preparation: Compile the submission packet, typically including the protocol, Investigator's Brochure (IB), Informed Consent Forms (ICFs) in local languages, and PI's CV/licenses.
- Submission Tracking: Assisting the PI with ethics committee submissions and track the status of the review.
- Query Resolution: Act as the primary contact for the EC, addressing any requests for modifications or clarifications to the study materials.
- Ongoing Maintenance: Once Clinical trial is approved, ensure all approval letters and stamped documents are filed in the Investigator Site File (ISF).
- Facility Preparation: Organize a tour of the facilities, ensuring that dedicated research space, pharmacy/storage equipped with temperature monitoring device, and labs are ready for inspection.
- Staff Coordination: Ensure the PI and key study staff are available to meet with the Clinical Research Associate (CRA).
- Equipment Verification: Verify that all required equipment (e.g., centrifuges, freezers) is present, calibrated, and maintenance logs are accessible.
- Recruitment Strategy: Prepare a clear plan for how the site will identify and enroll the target patient population to present to the CRA.
- Regulatory Binder (ISF): Begin organizing the Site Regulatory Binder with essential documents like the fully executed CDA, FQ, and staff training records.
- Financials: Reviewing study budgets, performing cost analyses.
- Communicating with CROs and Sponsors.
- Approvals: Verify that final EC approval letters, approved Informed Consent Forms (ICFs) with version dates, and all regulatory notifications, approvals and CTRI are filed.
- Financials: Confirm the fully executed Clinical Trial Agreement (CTA)
- Staff Records: Ensure signed and dated CVs, medical licenses, and GCP certificates for the Principal Investigator (PI) and all delegated staff are present.
- Delegation Log: Prepare the Delegation of Authority (DOA) Log with all names and roles; it must be signed by the PI and each staff member during the SIV.
- Participant Recruitment: Identifying, screening, and enrolling eligible subjects based on specific inclusion/exclusion criteria.
- Informed Consent: Leading or supporting the Informed Consent Process to ensure participants understand risks and benefits.
- Visit Coordination: Scheduling and conducting patient visits, coordinating with labs and pharmacies, and performing basic clinical tasks like vitals or ECGs.
- Source Documentation: Proper Documentation of trial and patient related activities.
- Study the Drug accountability.
- Maintaining the sample labeling and Dispatching.
- Supporting CRA for Query resolution during Interim Monitoring Visit.
- Data Management: Entering accurate data into Electronic Data Capture (EDC) systems and resolving queries from data managers.
- Experience of using various Electronic Case report Form such as Oracle, Inform, Clinion, Medidata Rave etc.
- Safety Reporting: Monitoring and reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) within strict regulatory timelines.
- ISF Setup and Maintenance: Organizing the initial Investigator Site File (often called the 'Regulatory Binder') with required templates, protocols, and investigator brochures before the study begins.
- Collection of Essential Documents: Gathering and filing site-specific records, including Personnel Records, Regulatory Approvals, Logs, and Document Flow to Sponsor.
- Version Control: Ensuring only the most current, approved versions of documents (like Informed Consent Forms or protocols) are in use and that expired versions are marked or moved to history.
- Quality Control & Audit Readiness: Conducting regular internal reviews of the ISF to identify missing or expired documents.
- Addressing TMF Queries or findings from monitors and auditors promptly to resolve discrepancies.
- Final Documentation: Completing final data entries, resolving outstanding queries, and reconciling investigational products (drugs/devices).
- Archiving: Ensuring all study records are properly archived for the mandated retention period to remain inspection-ready.
- Reconciling the ISF at the end of the trial to ensure all documentation is finalized and safely archived for the mandated retention period.
- Faced DCGI Audit.
- Faced Sponsor Audit.
- Faced USFDA Audit.
