Clinical Research Associate Senior
il y a 4 jours
We are seeking a highly skilled and experienced Senior Clinical Research Associate to join our team at Allucent. As a Senior CRA, you will play a critical role in the success of our clinical trials, ensuring that they are conducted in accordance with Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and applicable regulations.
Key Responsibilities- Provide functional assistance to project team members with administrative, logistical, and practical issues, including tracking, collection, distribution, and filing of study documentation.
- Track and supervise the collection of ongoing study data for regular project status reporting.
- Assist the Clinical Operations Manager in conducting feasibility assessments for potential studies.
- Ensure minimum quality standards for trial monitoring activities, including documentation, punctuality of reporting, compliance with objectives, and cooperation with other project team members.
- Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
- Collect and review regulatory documents as required.
- Prepare site visit and telephone reports.
- Responsible for multiple projects and must work both independently and in a team environment.
- May participate in the study development and start-up process, including reviewing protocols, drafting the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
- Resolve site issues and determine status for IP shipment.
- Work with Project Manager (PM), Clinical Team Leader (CTL), and/or Lead Clinical Research Associate (LCRA), regulatory team members, or Sponsor to secure authorization of regulatory documents and contracts.
- May translate, coordinate translations, or review completed translations of critical documents.
- Participate in feasibility and/or site identification activities.
- Assist the Project Team with the day-to-day management of clinical studies as required.
- Monitoring Visit Report (MVR) review, management, resolution, and escalation as required.
- Train, mentor, and/or supervise junior staff.
- May be assigned as LCRA to a regional or global study.
- May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
- Conducts project co-monitoring, assessment visits, and team training.
- Site contact for protocol clarifications and subject enrollment if CRA unavailable.
- Participate in the development of study newsletters communication as required.
- Assist with the development of project-specific training materials for the team.
- Liaise with Business Development and make presentations to potential clients as required.
- May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).
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