Opening for Clinical Research Associate ( Regional CRA ) @ Aarna Consultancy - Mumbai, IN
Job description
JOB DESCRIPTION -
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
Click here to apply
Job description
JOB DESCRIPTION -
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
Click here to apply
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