Manager, Clinical Research
Reports To Primary Investigator/Assistant Director, Clinical Research
Job Code 072212
Department As Assigned
Job Status Non-Bargaining
Location As Assigned
Job Grade 30
Scope The MetroHealth System
FLSA Status Exempt
Coordinates and manages the day-to-day operations of the research department.
Supervises the staff under the delegation of responsibilities as mandated
by the licensing regulations of the various health regulatory agencies.
Upholds the standards of the system-wide customer service and compliance
1. Coordinates the recruitment and screening of subjects for eligibility
as described in protocol.
2. Coordinates obtaining informed consent by the research coordinators
prior to performing/scheduling any study procedures. Informed consent
is a continuing process throughout the clinical trial.
3. Assures the study is conducted as specified in protocol; assuring
all specifics of protocol are met and notifies IRB of deviations/violations
from study procedures.
4. Assures subjects are scheduled according to schedule of evaluations
5. Assures subjects are registered for study visit in EPIC so that the
research account is correctly charged.
6. Provides any necessary training/instruction to research staff and
ancillary departments so required procedures are performed in accordance
with protocol and under state licensure regulations regarding delegation
and management of licensed staff (RN, LPN, OT, PT, LISW and RD).
7. Maintains accurate and complete source documentation to meet FDA,
sponsor and all applicable regulatory agency regulations/requirements.
8. Notifies IRB and sponsor of adverse events in accordance with IRB
and sponsor guidelines.
9. Assures the accuracy of case report forms (CRF) and that reporting
time requirements are met.
1. Supervises study personnel within the scope of state regulatory agencies
with regard to managing/delegating licensed personnel.
2. Participates in the identification of relevant new studies.
3. Prepares initial application to IRB for approval to conduct study
according to IRB guidelines and subsequent amendments.
4. Coordinates all site visits, which may include pre-study, initiation
and closeout visits with key personnel.
5. Identifies all tasks that need to be performed by study personnel
and delegates tasks according to state licensure regulations. Meets,
where applicable, with ancillary departments to determine the willingness/ability
of those departments to participate in study. Determines staffing requirements
and qualifications of staff to conduct study.
6. Maintains accurate and essential documents as required by FDA, IRB,
sponsor and other regulatory agencies or funding agency.
7. Trains staff and plans staff assignments in conducting studies.
8. Submits to PI and IRB the initial investigator's brochure and subsequent
9. Coordinates monitoring visits with clinical research associate (CRA)/sponsor
monitor and acts as liaison with PI and monitor/sponsor.
10. Coordinates closeout of study with key personnel.
11. Prepares/assists with grant application.
12. Prepares abstracts as required by department.
13. Develop positive working relationships with ancillary departments
to ensure smooth study progress.
14. Acts as liaison between principal investigator and the IRB.
15. Prepares advertising for recruitment of subjects (requires prior
IRB approval) per department requirements.
16. Keeps abreast of FDA, IRB and other regulatory agency compliance
requirements and subject safety issues.
17. Maintains data integrity.
18. Monitors research project activity to ensure compliance with appropriate
regulatory agency requirements/regulations and protocol design.
19. Manages study supplies where applicable.
20. Manages record retention according to FDA, IRB and other regulatory
agency and sponsor guidelines.
21. Assists in preparing for FDA and internal audits.
22. Interviewing, training, supervising and evaluating assigned personnel
within the scope of professional practice.
23. Support research and education efforts and opportunities for staff
by remaining informed of current research that affects their practice.
24. Developing and implementing operational systems to improve departmental
25. Performs other functionally related duties as assigned.
1. Prepares study budget as required. Works closely with the Research
Administration Business Office and grants management specialist assuring
all required documents are submitted in application.
2. Collaborates with investigator and business manager to determine
economic feasibility of proposed studies.
3. Reviews and approves study invoices for payment. Determines all invoices
are received for services provided by ancillary staff.
4. Meets regularly with their assigned Grants Management Specialist
to review budget.
Bachelor's Degree in a health-related field (i.e., Nursing, Nutrition,
Social Work or other Health Profession).
Knowledgeable of all regulatory requirements in conducting research
involving human subjects.
Three years combined clinical research and management experience.
Outstanding interpersonal, written and verbal communication skills.
Good organization and problem solving skills.
Proficiency in personal computers and various software and database
Current CPR card if providing direct patient care.
Knowledgeable of good clinical practices (GCP) in research.
Ability to work independently.
Good motivational skills.
Excellent management skills.
Note: May be additional requirements including competencies as required
by the department that will be indicated on the position posting.
Master's degree in health or related field.
Certified clinical research coordinator (CCRC).
Experience in Institutional Review Board (IRB) process.
Experience in budget preparation.
Knowledgeable in area of department specialty.
I have read and
understand the job description and qualifications for the position for
which I have applied.