An exempt position that under the administrative direction of the practice Administrator and clinically under the Principal Investigator manages the conduct of clinical research activities and participates as an active member of the clinical research administrative committee.
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 clinical practice.
Ensure that all aspects of GCP are complied with at all times through provision of training at start-up and initiation meetings for clinical trials and on-going SOP development.
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.
Coaching of CRAs in various aspects of management (eg HR, budgets, resource allocation) that are relevant to particular project issues.
Implement training programs for CRAs and other clinical staff with topics that include: principles and practices of project management, team communication, computer software and IT training, protocol and CRF writing, adverse event reporting and the importance of pharmacovigilance, and budget control and reporting.
Responsible for human resources activities and management for the Research Department. HR activities are to be coordinated with Administration and with outside consultation with the HR resource.
Provides Administration and the Research Committee with monthly program activity reports.
Processes all outside resources, review for services provided, and forward to Administration for prompt processing and payment. (Accounts Payable)
Monthly bill sponsors for services rendered, providing a copy to the bookkeeper for reconciliation with sponsorship payments.
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.
Work with Administration to document all passwords for all files to maintain double backup for all files. All passwords will be maintained in the Administrator's office. No password can be established without providing the password to Administration for filing.
All files and patient charts will be secured.
Practice Development: The Research Manager will work with Administration and the Research Committee to develop an active informative policy and procedure manual to guide clinical research activities.
Education: Minimum of RN or above nursing degree.
Experience: Five+ years’ experience and training in conducting clinical research, 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