Clinical Research Coordinator - AAKASH HEALTHCARE SUPER SPECIALITY HOSPITAL - DWARKA, NEW DELHI
(2024-06)
- Coordinate and manage day-to-day operations of clinical trials in accordance with study protocols, ICH-GCP guidelines, and institutional requirements.
- Screen, consent, and enroll eligible study participants; maintain accurate documentation of recruitment activities and subject eligibility.
- Conduct study visits, collect and process biological samples, perform study-related assessments, and ensure timely completion of case report forms (CRFs).
- Maintain essential regulatory documents, including IRB or EC submissions, continuing reviews, protocol amendments, and adverse event reports.
- Maintain documentation and timely communication of EC decisions, determinations, and required modifications to investigators.
- Provide ethical oversight during study conduct, including ensuring that protocol deviations, SAEs, and complaints are handled appropriately.
- Participate in EC discussions and decision-making on protocol approval.
- Serve as primary liaison between investigators, study sponsors, monitors, and clinical staff to facilitate study compliance and resolve protocol-related issues.
- Conduct EC meetings, prepare minutes (MoM), and issue approval letters ensuring timely and accurate documentation of Ethics Committee decisions.
- Ensure participant safety by tracking and reporting adverse events and coordinating follow-up care as required.
- Maintain accurate research data through effective data entry, query resolution, and quality control checks within electronic data capture (EDC) systems.
- Manage investigational product (IP) accountability, including receipt, storage, dispensing, and reconciliation in collaboration with the research pharmacy.
- Train new staff and support workflow development to improve study efficiency and participant experience.
- Track and report adverse events, including serious adverse events and treatment-related toxicities.
- Support investigational drug accountability and study start-up activities.
- Contributed to high standards of research integrity by ensuring timely reporting and evaluation of SAEs, deviations, and safety updates.
- Successfully screened and enrolled high-acuity oncology patients, improving recruitment rates and meeting sponsor enrollment targets.
- Ensured timely AE/SAE reporting—particularly for immune-related and treatment-emergent toxicities—improving safety oversight and regulatory compliance.
Clinical Research Coordinator (Trainee CRC) - MEDANTA THE MEDICITY - GURUGRAM, INDIA
(2022-11 - 2024-06)
- Provide general support to the operations clinical research team according to needs in a clinical research department.
- Ensured adherence to established regulatory and guidelines.
- Worked closely with the research team to implement smooth project management.
- Assisted in study start up activities: Feasibility, SIV, Protocol Training, CTA.
- Ensured the compliance with the guidelines and maintaining the confidentiality of the participants.
- Preparation of all the documents required for Submission to Ethics Committee.
- Dossier submission to the EC.
- EC related study documents submission and notify in all additional document, Annual Report and protocol amendment, ICF.
- Arranging the data according to protocol requirement and anonymizing few tags in order to maintain the confidentiality.
- Maintain accurate and up to date study documentations.
- Research operation – CTA and clinical trial budget as per institutional policies and sponsor requirement.
- Assisted in management of clinical trial activities (from study startup to closeout), Essential Documentation, SSV, SIV, patient visit, EC communication, Logs, Invoice, EDC, IP handling.
- Informed Consent (Paper and Audio-Visual).
- SAE/AE reporting to EC & regulatory.
- Trial Master File (TMF/eTMF), Investigator Site File (ISF) maintenance and preparation before, during and after the conduct of the study.
- Handle observational studies in ICU.
- Assisted in Public health Survey (field visit and guide the public related to their health) – Anemia Muhkt Haryana and fill the CRF and EC F for data collection.
- Assisted in Data entry under CTN (BIRAC) project.
- Data review with compliance of SOP.
- Review ICF according to schedule 3 ICF checklist.
- Assisted in Informed consent form to patient and involved his/her in clinical Trials.
Pharmacist (Assistant Pharmacist) - PARK HOSPITAL, SOUTH CITY - GURUGRAM, INDIA
(2021-08-25 - 2022-08-30)
- Responsible for managing the procurement, storage and dispensing of medication.
- Handle over 15+ prescription per day including discharge medication.
- Trained pharmacy residents and interns on clinical care medication dispensing.
- Gave Instructions to patients on proper use, side effects and how to take the prescribed medicines.
- Organizing the pharmacy, delivering and labelling medications.
- Generating Bills of IPD or OPD prescription.
- Worked on software such as Vipha, Easysol Mark etc. for generating billing invoices.
