| Pharm-Olam is currently seeking experienced Senior Clinical Research Associates for full-time, direct hire positions. All positions are home-based. Specifically we are looking for strong experience in the following therapeutic areas and regions: - General Medicine - Central
- ID & Vaccine - Central / East / West
- Immunology - West
- Oncology - West
- Rare Disease - Central / West
Ideal candidates should have full site management/monitoring experience, and be willing to travel. Responsibilities - Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
- Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.
- Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies.
- Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
- 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 of 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 enrolment if CRA unavailable.
- Participate in the development of study newsletters communication as required.
- Assist with the development of project-specific training materials for 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).
- Other duties as assigned by Management.
|
