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Senior Clinical Research Associate

3 weeks ago

Riyadh, Saudi Arabia Ray-Cro Full time

Responsible for the management of clinical trials including investigator selection, analysis of potential patient recruitment, preparation of trial related documentation (Protocols, Case report forms, Investigators brochures, Consent documents, Letters of Agreement, Confidentiality Agreements), organizing trial related regulatory submissions with follow-up to ensure successful outcome.
- Organize investigator’s start-up meeting and study site initiation meetings.
- Ensure that proper drug accountability is maintained in assigned clinical trials sites.
- Verify all data entries on case report form with source documents.
- Responsible for prompt reporting and follow-up on all adverse experiences, as required by Protocol, Applicable Regulations and SOPs.
- Monitoring the assigned clinical trial in accordance with Protocol, Monitoring Plan (if applicable) and SOPs.
- Planning the requirements for clinical trial materials, ordering clinical trial materials [CTMs] (From Sponsor) setting up and monitoring the systems
- Keep the study trial master files up to date for all assigned projects to ensure compliance with local, legal and ethical requirements for study conduct.
- Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly sent to Data Management or entered into the database.
- Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigator brochure; protocols; case report forms instructions; consent documents; CTMs shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all internal & external correspondences.
- Administer protocol and study related trainings to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Ensure the quality and integrity of study site practices is compliant with the protocol and applicable regulations and SOPs. Escalate quality issues to Clinical Operations Manager (COM).
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
- Manage patient recruitment strategies (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to PIs).
- Closely working with the COM, assuming responsibilities when required.
- Participate in departmental planning sessions.
- Provide management to the clinical trial assistants to ensure that their role and contribution is optimized when required.
- Report Issues of Serious GCP non-compliance, misconduct and fraud as appropriate.
- Lead & couch a group of CRAs if requested.
- Share the higher management in the training of CRAs.

**Qualifications**:

- Education: Pharmacist / Medicine / Dentist.
- Experience: Minimum 2 years in clinical research field
- KSA Residency