The responsibility of a Clinical Research Associate (CRA) is to perform all clinical
monitoring aspects of designated projects in accordance with applicable
SOP and regulations. Responsibilities include performing clinical
on-site monitoring activities (drive patient recruitment, source data
verification, drug accountability, and data collection), collecting
regulatory documentation (when required), performing qualification,
initiation, monitoring and termination of investigational sites in
accordance with ICH GCP guidelines.
Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM
Preparation, conduct and reporting of site selection visits
Negotiation & obtaining Investigator agreement on site budget, payment to the sites
Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner
Maintenance of TMF and Site specific file
Scanning & uploading documents into shared drive
Transmission of documentation into project files
Preparation of regulatory dossier, regulatory submission and follow-up.
Preparation of EC dossier, EC submissions and follow-up
Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting
Development of meeting materials along with required presentations for investigators meeting.
Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
Co-ordinating the IP request between sites and pharmacist/vendor/sponsor
Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM
Preparation, conduct and reporting of site selection visits
Negotiation & obtaining Investigator agreement on site budget, payment to the sites
Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner
Maintenance of TMF and Site specific file
Scanning & uploading documents into shared drive
Transmission of documentation into project files
Preparation of regulatory dossier, regulatory submission and follow-up.
Preparation of EC dossier, EC submissions and follow-up
Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting
Development of meeting materials along with required presentations for investigators meeting.
Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
Co-ordinating the IP request between sites and pharmacist/vendor/sponsor
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy
PG:M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
PG:M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
- Worked in OPHTHALMOLOGY or ONCOLOGY or DIABETES studies Clinical Studies I-IV
Ability to interact professionally with clients/vendors
Excellent interpersonal, verbal and written communication skills and ability to work in a team
Effective time management skills and prioritize tasks to manage study timelines
Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word etc, sound presentation skills
Willing to travel a minimum of 65% on average
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