Job ID: 214383117
5 - 10 years
Director of Clinical Research
The Director of Clinical Trials manages and participates in the clinical trial activities.
Essential Job Responsibilities:
- Assume overall responsibility for the preparation of protocols and Case Report Forms, finalization of monitoring and data management options (either in-house or contracted to a Contract Research Organization), development of recruitment strategies to increase patient randomization into the trial, the provision of clinical trial materials, and management of the trial.
- Recruitment of studies appropriate to the practice’s specialty.
- Ensure that all aspects of GCP are complied with at all times.
- Coordinate the smooth monitoring of all trials by identifying and managing qualified staff, establishing audit procedures and ensuring that cleaned data is entered into the database in a timely fashion.
- Participate in Administrative Clinical Research Department meetings and Clinical Research Team meetings ensuring that colleagues are updated on all relevant issues.
- Ensure the smooth running of the clinical research department by developing systems to track projects including all study and investigator information, patient recruitment activity and financial management.
- Participate in the financial management of the clinical trial program including budget planning, resource allocation and preparation of monthly reports.
- Coaching of CRAs in various aspects of management that are relevant to particular project issues.
- Implement training programs for CRAs and other clinical staff .
- Responsible for human resources activities and management for the Research Department.
- Provides Administration and the Research Committee with monthly program activity reports.
- Invoices sponsors for services rendered.
- Works as a team member with all clinical departments administratively and clinically.
- Know and understand all regulatory requirements associated with the conduct of the study assigned.
- Maintain files and documents as regulations dictate.
- Ensure all required documentation is complete and appropriately filed.
Management of site activities during audits and inspections:
- Prepare for quality assurance audits and regulatory inspections as needed.
- Act as contact person before, during and after audits and inspections.
- Provide all required documentation to auditors.
- Make all appropriate corrections as requested by auditors.
- Coordinate site response to audit/inspection findings.
- Maintain all clinical trial contracts and budgets in an organized manner.
- Responsible for the security of all study related files, study binders and any other study related documents.
Education: CRC; LPN or above nursing degree desired
Experience: Five+ years’ experience and training in conducting clinical trials, reporting source documentation, and trial management.
Other Requirements: A thorough understanding of regulatory requirements and principles of GCP and biomedical research ethics.
IATA certification for specimen collection, packing, and shipping.
Interpersonal and communication skills—interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.