Job Description
At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are looking for a Sr. Clinical Research Associate Contractor (SrCRA) to join our A-team (remote). As a SrCRA Contractor at Allucent, you will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.
In this role your key tasks will include:
- Governs highest possible quality standards for trial monitoring activities.
- Conducts all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours.
- Monitors activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines:
- Performs efficient site management in line with study budget.
- Prepares and submits quality Site Visits Reports and Contact reports.
- Maintains and updates CTMS in compliance with SOPs and study-specific directives.
- Acts as Document Owner for collected documents.
- Conducts co-monitoring as needed.
- Provides functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF).
- Liaises with project team members and Sponsor to track study progress and milestones.
- Tracks and supervises collection of ongoing study data for purpose of regular project status reporting within agreed timelines.
- May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
- May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training.
- May perform assessment visits.
- Represents Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel.
- Identifies potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution.
- Acts as the lead contact in case several CRAs involved for a same study in same country.
- Supervises generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed.
- May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable.
- May participate in meetings with clients.
- May support project manager/CTL and project functional leads in the project oversight and management.
- Supports site staff in preparation for study related site audits and inspections.
- Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions.
