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Clinical Research Facility Manager

2 months ago

London, Greater London, United Kingdom Clerkenwell Health Full time
Main Purpose of Role:

Clerkenwell Health is a leading Research Organisation specialising in the delivery of scientifically grounded Clinical Trials. As a Clinical Research Facility Manager, you will be responsible for the day-to-day management of the Clinical Research Facility and the management of the Nursing and Operational Team within that facility.

Main Duties and Accountabilities:
  • Strategy:
  • Work with the Senior Leadership Team on all Business Development tasks to support the CRF.
  • Provide professional leadership to all operational staff at all levels throughout the CRF.
  • Oversee and/or assist in the recruitment and on-going management of CRF staff team.
  • Maintain an awareness of best practice with regard to managing and developing staff using appropriate team building and change management skills.
  • Contribute to the development of training programmes as required.
  • Finance and General Management:
  • Contribute to the management, monitoring, control, and reporting of budgets.
  • Advise on financial and contractual management for projects and awards.
  • Oversee the vendor selection process and vendor management.
CRF Overview:
  • Undertake nursing activities relating to clinical trials from start-up to close-out.
  • Review research protocols and identify training and education requirements.
  • Ensure the commercial success of the site by contributing to participant recruitment and retention.
  • Screen and randomise potential study participants.
  • Conduct informed consent discussions and take informed consent.
  • Ensure completion of study procedures such as phlebotomy, vital signs, and ECG.
  • Schedule trial visits and track enrolled participants.
  • Complete and organise regulatory documents.
  • Communicate with sponsors, regulators, and third-party vendors.
Clinical Trial Management:
  • Obtain informed consent from participants for CTIMP and non-CTIMP studies.
  • Support participants considering participation with the decision-making process.
  • Ensure all adverse events are reported in line with the protocol.
  • Facilitate and maintain communication between the PI, research, and clinical teams.
  • Ensure the appropriate execution of all visits and clinical procedures.
  • Ensure all laboratory work is completed as per study protocols.
  • Provide ongoing support to patients and volunteers.
  • Ensure all clinical trial databases and logs are maintained.
General Clinical Duties:
  • Support colleagues in assessing, planning, and implementing high-quality care.
  • Work with the CRF team to ensure the safe custody, maintenance, and administration of medication.
  • Promote and maintain a safe therapeutic environment for patients, their families, and staff.
  • Provide sound evidence-based advice to staff and patients.
  • Maintain a good understanding and implementation of clinical escalation procedures.
Resource Management:
  • Plan resource and capacity for CRF operations as new trials are assigned.
  • Ensure the CRF is adequately staffed.
  • Support senior colleagues in ensuring research delivery within capacity.
  • Manage the physical resources required to undertake research activity.
Administrative Duties:
  • Support the research team, sponsors, and CRO in the maintenance of investigator site files and working files.
  • Complete Case Report Forms (CRFs) with a high degree of accuracy.
  • Set up and maintain study trackers.
  • Implement study amendments.
  • Locate and track medical records.
  • Manage and participate in monitoring visits.
  • Oversee filing of research material.
  • Complete annual monitoring study reports.