Regional Clinical Research Associate
- Job Responsibilities
1 Overseeing all aspects of the clinical trial process. Ensuring trials are conducted, recorded and reported according to the protocol, standard operating procedures, good clinical practice and applicable regulatory requirements
2 Perform Site Identification and conduct Feasibility Studies.
3 Perform Site Selection Visit, Site Initiation Visits in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
4 Perform Site Monitoring Visit and Site Close-Out Visit in accordance with the protocol and other applicable regulatory guidelines including local regulatory guidelines.
5 Writing pre-visit letters, follow up letters and site visit reports.
6 Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, protocol related activities.
7 Maintain accurate and timely sponsor/site correspondence and communication.
8 Conduct training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines.
9 Prepare Ethics Committee Submission Dossier.
10 Maintain updated Site Files and collection of the essential documents and project related documents during the site visits and maintain Central Clinical File.
11 CRF retrieval as per the Clinical Management Plan.
12 Control investigational product accountability through physical inventory and records review. Control trial supplies ordering & dispatch of investigational product to site.
13 Ensure the proper essential documents are in place prior to trial start up and on an ongoing basis throughout the study.
14 Ensure administrative set up of sites, laboratories, storage facilities, equipment, etc.
15 Facilitate effective communication between investigational sites and the lambda project team through written, oral and electronic contacts
16 Archival of study documents.
17 Knowledge of ICH-GCP, FDA and all applicable guidelines in conducting Clinical Trial
18 60 % of the time would be travelling
Sr. No. SKILLS/COMPETENCIES (FUNCTIONAL/TECHNICAL)
1 Open and clear communicator
2 Confident and influential approach
3 Understand the needs of others
4 Recognise potential obstacles and work to resolve them within set timelines
5 Conscientious and precise delivery of work even when under pressure
Veeda Clinical Research Pvt Ltd
Veeda was established with a vision of creating an organization with a scientific edge, technical skills and better foresight for clinical trials; with an objective of becoming a catalyst for enhanced drug developments to facilitate better patient treatments. We aim to become the most desired partner to the Pharmaceutical fraternity globally in their clinical studies to deliver safe and quality solutions with no compromise on ethical practices.
At Veeda, we place a firm emphasis on following our value system to deliver excellence in our clinical trials. Our values and commitment to innovation, perfection and quality have helped us to establish ourselves as one of the safest and most trusted CRO in India
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