
Clinical Research Associate
1 week ago
Responsibilities & functions: Clinical Research Associate
- Working in accordance with ICH E6 principles and with applicable SOPs (either ECRON AcuNova or Sponsor's SOPs) & local regulatory norms.
- Review of study synopsis.
- Site selection.
- 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.
- Site monitoring visit planning, preparation, conduct, report and follow-up of pending issues.
- Remote Monitoring, Central Monitoring and Risk Based Monitoring related activities.
- Accompanied visit as a part of mentoring a new CRA.
- Interacting with DM for data transfer and query resolution.
- Interacting with MW for CSR appendices.
- Preparation of project status report.
- Preparations, participation in meetings and documentation of meeting minutes.
- Provide oversight to project (maintaining quality & timelines of deliverables).
- Participate in client QA assessments.
- Reconciliation Filing of project correspondence.
- Site close-out visit planning, preparation, conduct, report.
- Maintenance of Investigator database and a QC of the database.
- Archival of study documentation. Participation in other department initiatives/activities.
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