Clinical Research Associate
Replacin Pvt. Ltd.
Requirement of Onsite Monitoring Experienced CRA in patient based study in Kozikode, Kerala.
Experience:
2-4 years Experience as an Onsite Monitoring CRA is Mandatory.
Location:
Kozikode, Kearala
Nadiad & Junagarh , Gujarat
Candidate Should Be From near by locations Only
1. Clinical studies shall be monitored at appropriate intervals or as per sponsor instructions /Agreement.
2. Head CT/ designee outsource the activity to external monitoring organization to serve as CRA, as applicable. The external CRA shall update and send the status of all monitoring visits in form of Monitoring visit reports, Visit follow-up letters, telephonic contact logs between external CRA and Study team.
3. CRA shall be responsible for preparing, conducting and documenting periodic clinical site monitoring visits.
4. The objectives of site monitoring shall be as below:
Provide ongoing oversight of clinical trial activities being conducted at site to ensure:
a) Adequate protection of the rights and wellbeing of human subject
b) The conduct of the trial is in compliance with applicable regulatory requirement, GCP guideline and the clinical study protocol
c) Monitor the Dosing Activity and post dose clinical activity to ensuring that it is conducted, recorded, and reported in accordance with the protocol.
d) Sometimes we need to monitor the dosing activity at patient site to ensure the proper doing activity done.
e) The reported clinical study data are accurate, complete and verifiable from source documents
f) Adverse events, concomitant medications and intercurrent illnesses are reported in accordance with the protocol on the CRFs
g) Determining whether all serious adverse events (SAEs) are appropriately recorded, handled and reported within the time periods as per the applicable regulatory requirement(s).