Work for M.Pharm/ M.Sc as Clinical Research Associate - Client of Winston HR Services

Our client is highly reputed client since a decade and having a multiple branch in Foreign as well as in INDIA.

Post: Clinical Research Associate

Job Description
• Excellent communication skills(written and verbal)
• Computer skills, ability to develop and maintain excel spreadsheets.
• Strong organizational skills with attention to details
• Excellent English.

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
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
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 Organizational 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
18. 60 % of the time would be travelling

Candidate Profile

Open and clear communicator
Confident and influential approach
Understand the needs of others
Recognise potential obstacles and work to resolve them within set timelines
5 Conscientious and precise delivery of work even when under pressure
Sr. No. SOFT SKILLS/COMPETENCIES
Computer skills including the ability to operate Microsoft excel and word
processing programs
Effective verbal and written communication skills
Flexible and open to change
Excellent inter personal skills
Time management skills

Additional Information:
Experience: 1-3 years
Location: Mumbai
Education: M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Department: Clinical Operation Department
Reporting to: Project Manager
End Date: 30^th April, 2015