Clinical Research Associate

Role & responsibilities

Participate in the investigator recruitment process. Perform initial qualification visits of potential investigators and sites. Evaluate the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.

Work with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.

Perform study initiation activities, reviewing with the site study team the protocol, regulatory issues, study procedures, and provide training on completion of the e-CRF; monitoring activities and study close-out activities.

Train site study team on the EDC system.

Conduct periodic site file audits to ensure compliance with GCPs and sponsors standard operating procedures.

Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.

Perform validation of source documentation as required by sponsor. Prepare monitoring reports and letters in a timely manner as per Clinical Trial Monitoring Plan.

Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records

Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture

Document accountability, stability and storage conditions of clinical trial materials as required by sponsor. Perform investigational product inventory. Ensure return of unused materials to designated location.

Review the quality and integrity of the clinical data through in house review of electronic CRF data and on-site source verification. Work with sites to resolve data queries.

Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.

Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF).

Coordination with central and corelab (Echocardiography, QCA, OCT/IVUS, ECG) involved in the clinical trial.

Review protocols, eCRFs, ICF and other related documents, as requested by Project Manager.

Assist with final date review and query resolution through database lock.

Online & offline regulatory/IEC submissions of different countries.

Coordination with DSMB, Steering committee, CEC and attend meetings and prepare minutes of meetings.

Preparation of study presentation for review meetings at Central Drug Standard Control Organization Regulatory Body of India.

Preparation of Study presentation for national & international conferences.