Ethics & Clinical Research Coordinator Expert

Bhargavi Porala

E-Mail: *********.**@*****.***

Contact: +91-967*******

Education:

****-****: M.Sc. in Clinical Research Institute of Clinical Research India, Priest University, Thanjavur - 84%

2008-2009: Post Graduate Diploma in Clinical Research Management, ICRI, Hyderabad - 83%

2004-2008: B-Pharmacy, Sri Padmavathi School of Pharmacy, Tirupati - 74%

Professional Experiences:

Designation

Organization

Duration

Ethics Committee Coordinator

CARE Hospitals, Hyderabad

Apr 2025-To Date

Investigator Site Coordinator

Star Hospitals, Hyderabad

Jan 2023- Mar 2025

Clinical Research Assistant

Clinispace Solutions Pvt Ltd

Feb 2021 - Dec 2022

Clinical Research Coordinator

NIMS, Hyderabad

Mar2012 - Jul 2012

Clinical Research Coordinator

KIMS, Secunderabad

Jan 2010 - Jan 2012

Job Responsibilities:

Ethics Committee Coordinator:

Accreditation of Ethics Committee process to strengthen the Ethics Committee as per NABH standards.

Serves as primary contact among Institution, EC, Investigators, Sponsors, CROs and DCGI to provide the accurate trial management at the clinical investigative sites including site facilities, site team’s qualification/ training, study approval, site initiation, subject’s recruitment/retention, informed consent process/ study visits/ follow-ups, Management of SAEs if any, Management of Protocol Deviations/Violations if any, maintenance of Individual Patient’s data/records and study close-outs/ its archival.

Coordinate EC activities like Agenda Preparation/organize EC meetings/ EC Minutes/ EC Approvals as required.

Support reporting of Serious Adverse Events (e.g., reviewing/ contributing to patient narratives, attendance of sub- committee meetings, reporting) as required.

Responsible to provide the query resolutions to the clinical trial team with accurate information for the raised queries during conduction of clinical trials.

Preparation of monthly and annual report on EC activities to report to Head of Care Hospital.

Conduct regular reviews and ensure timely renewal of DHR, NABH and CDSCO website registrations.

Preparing the site for the NABH Audits.

Submit 30 Day reports through the SUGAM Portal in compliance with regulatory requirements.

Prepare and compile annual reports of the Ethics Committee.

Develop, review and maintain Standard Operating Procedures (SOPs) for the EC.

Investigator Site Coordinator:

Conduct feasibility assessments for clinical studies.

Participate in identifying potential investigators and clinical sites.

Assist in preparing Investigator’s meetings.

Ensure timely delivery of trial supplies and materials to investigators.

Track and manage study documents for all sites.

Coordinate Ethics Committee submissions.

Report activities to the Principal Investigator.

Preparing study-related documents for IEC submission per regulatory and ICH-GCP guidelines.

Actively participate in patient recruitment and patient follow-up visits as per the protocol.

Update patient data in CRFs and Google sheets promptly and accurately.

Maintain regular communication with other coordinators to ensure smooth trial progression.

Clinical Research Assistant:

Collate information on the investigator (Indication wise, Region wise) and update the Investigator database for ongoing/ upcoming trials.

Overall site management of clinical trials ensuring that projects are progressing according to contract and defined quality standards, Protocol, SOPs, GCP and other applicable guidelines to fulfil local regulations.

Ensures the communication to sites about the project scope of work, timeline and project goals, technical information, and input from PM throughout the project.

Preparation of site visits includes, Site Qualification, Site Initiation, Site Monitoring, Site Closeout, Pre-audit etc.

To check Site initiation visits which include ensuring each site has the trial materials and training of site staff to trial specific and industry standards with PM and to prepare reports.

To check Site Monitoring Visits and Close Out Visits and to prepare reports.

To Prepare the Site Activation checklist

Ensure communication with sites for ethics committee notifications of Serious Adverse Events, Study Progress, Protocol Deviations, and Safety Reporting

Reviewing of Monitoring Reports

Create and maintain appropriate documentation regarding site management, monitoring visit.

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission and data query generation and resolution.

Maintaining up to date in-house data bases including site details, AEs, protocol deviations and financial tracking.

Ensure the accuracy and timely completion of case report forms and facilitate the transfer of CRFs to the data management

To support and co-ordinate with the site staff and data management for the query resolution during data cleaning cycle and Data Base Lock

Regulatory Submissions i.e. preparation of Dossier, submission of Safety related information.

Clinical Research Coordinator:

Worked with EDC for data transmission.

Managed initial data entry of case reports and reviewed reports for seriousness, causality, and expectedness.

Prepared study-related documents for IEC submission per regulatory and ICH-GCP guidelines.

Assisted in preparing sites for SSV, SIV, monitoring, and closeout visits.

Counselled patients and reported to investigators, including obtaining informed consent and managing patient randomization via IVRS/IWRS.

Administered lab tests, monitored vital signs, and maintained drug inventory as per protocol guidelines.

Collected, processed, and shipped specimens, and documented trial activities in the Trial Master File as per GCP standards.

Handled adverse events and serious adverse event reports to IEC and sponsors.

Clinical Research Projects:

PREDICT Study: ICMR-funded Principal Investigator Trial

Focus: Prospective evaluation of graft patency and outcomes in diabetics undergoing coronary artery bypass grafting.

PROMOTE Patency Trial: Principal Investigator Trial

Focus: Long-term outcomes of off-pump and on-pump coronary bypass in a randomized trial.

CLAF237A23118 Study: Novartis Trial

Focus: Effect of vildagliptin on left ventricular function in patients with type 2 diabetes and congestive heart failure over 52 weeks.

ALECARDIO Study: IQVIA (Quintiles) Trial

Focus: Cardiovascular outcomes study to evaluate Aleglitazar's potential in reducing cardiovascular risk in patients with recent acute coronary syndrome (ACS) and type 2 diabetes.

TRIOLOGY Study: IQVIA (Quintiles) Trial

Focus: Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) patients with unstable angina/non-ST-elevation myocardial infarction (UN/NSTEMI).

Certificates:

ICH-GCP Completion Certificate, awarded by NIH Pharma XM, Alecardio Quintiles, Novartis, & The Global Health Network.

Personal Profile:

Nationality: Indian

Marital Status: Married

Linguistic Abilities: Telugu, English & Hindi

Address: Gandhi Tata nagar, Khairatabad, Hyderabad - 500004

Declaration:

I hereby declare that all the information provided in this resume is true and accurate to the best of my knowledge and belief.

Bhargavi Porala

Contact this candidate