Eligibility criteria ,
- Life science graduate
- Minimum 2 year of experience as a CRC
Job Description:
o Conduct site/trial feasibility to identify & select the right site and investigator for the study
o Ensure timely compilation of all essential documents & assist in regulatory package preparation, timely submission, follow up with site EC to resolve any queries, and obtain approvals
o Ensuring site setup according to protocol, review patient data base & pre-screening, identify physician network
o Coordinate for Clinical Trial Supplies receipt, accountability & storage
o Prepare site team for study initiation visit and coordinate with monitor for the visit
o Assist in the process of administering the informed consent to the potential Subjects and discussing in detail the patient information sheet
o Ensure that site documentation remains current, accurate and complete
o Coordinate for lab samples collection and logistics; review of lab reports and update PI
o Review & implement appropriate recruitment/referral activities for active enrolment at sites
o Ensure CRF Completion and query resolution on specified timelines
o Coordinate in conduct of Monitoring visits and Audits (Internal or External)
o Ensure that monitoring/audit related findings are resolved within the timelines
o Ensure patient follow up visit and vist compliance; manage patient related reimbursement; site related payment
o Drug receipt, accountability, storage, dispensing and related documentation
o Ensure adherence to protocol guideline, regulations, ethical guidelines
o Coordinate and ensure timely reporting to all stakeholders
o Maintain study log(s) & study manuals
o Assit monitor with the site closeout activities
o Manage final reconciliation of Clinical Trial Supplies and archival of study documents at sites
APPLY ONLINE
- Life science graduate
- Minimum 2 year of experience as a CRC
Job Description:
o Conduct site/trial feasibility to identify & select the right site and investigator for the study
o Ensure timely compilation of all essential documents & assist in regulatory package preparation, timely submission, follow up with site EC to resolve any queries, and obtain approvals
o Ensuring site setup according to protocol, review patient data base & pre-screening, identify physician network
o Coordinate for Clinical Trial Supplies receipt, accountability & storage
o Prepare site team for study initiation visit and coordinate with monitor for the visit
o Assist in the process of administering the informed consent to the potential Subjects and discussing in detail the patient information sheet
o Ensure that site documentation remains current, accurate and complete
o Coordinate for lab samples collection and logistics; review of lab reports and update PI
o Review & implement appropriate recruitment/referral activities for active enrolment at sites
o Ensure CRF Completion and query resolution on specified timelines
o Coordinate in conduct of Monitoring visits and Audits (Internal or External)
o Ensure that monitoring/audit related findings are resolved within the timelines
o Ensure patient follow up visit and vist compliance; manage patient related reimbursement; site related payment
o Drug receipt, accountability, storage, dispensing and related documentation
o Ensure adherence to protocol guideline, regulations, ethical guidelines
o Coordinate and ensure timely reporting to all stakeholders
o Maintain study log(s) & study manuals
o Assit monitor with the site closeout activities
o Manage final reconciliation of Clinical Trial Supplies and archival of study documents at sites
APPLY ONLINE
