Job ID: 157998078
Job Description – Clinical Research Manager
Job Title: Clinical Research Manager
Department: Clinical Research
Immediate Supervisor Title: Practice Administrator
Job Supervisory Responsibilities: General supervision of Clinical Research Department staff.
General Summary: An exempt position that under the administrative direction of the AIU 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:
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 AIU clinical research activities.
Education: Minimum of LPN 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
Equipment Operated: Medical instruments required for physical exams and computer hardware/software.
Work Environment: Medical office and exam room settings. Frequent exposure to communicable diseases, biohazards, and other conditions common to clinic. Frequent contact with variety of people.
Mental/Physical Requirements: Involves standing, sitting, walking, bending, stooping, and twisting. May be required to help to transfer patient. High level of responsibility and heavy workload can generate stress.