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To be associated with pharmaceutical industry that would provide a challenging work atmosphere and an opportunity to learn, grow and contribute to its growth with professional's team & to obtain a respectable position which will enable me to use my talents, creativity and ability to the maximum, and contribute to the growth of organization as well as myself. To use academic knowledge and skills to pursue a career in Clinical Research including Health Care Profession and also to take care of patients. Professional experience of 13 years as Clinical Research Coordinator.

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.

PGDCR - Clinical Research - Academy of Ethical Clinical research at Gatewell Hospital Dhantoli (2011)

BHMS - Homeopathy - Antarbharati Homeopathic Medical college, Nagpur (2011)

H.S.C. - Abhinandan Jr Science College, Nagpur (2005)

S.S.C. - New English High School, Nagpur (2002)