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: 30th April, 2015
If you are interested for the above position, please revert with your updated CV to winstonhrservices@gmail.com
Posted by,
Purvi Patel
Client of Winston HR Services
See All Ph.D Alerts B.Sc Alerts B.Pharm Alerts D.Pharm Alerts
See All Other Jobs in our Database
.png)
