Clinical Research Manager, Pediatrics, Neonatology

Clinical Research Manager, Pediatrics, Neonatology

Wake Forest Baptist Health is a pre-eminent academic health system based in Winston-Salem, North Carolina. Wake Forest Baptist’s two main components are an integrated clinical system – anchored by Wake Forest Baptist Medical Center, an 885-bed tertiary-care hospital in Winston-Salem – that includes Brenner Children’s Hospital, five community hospitals, more than 350 primary and specialty care locations and more than 2,500 physicians; and Wake Forest School of Medicine, a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery.

The Research Manager will report directly to the Vice Chair of Research for the Department of Pediatrics and be responsible for oversight of all research coordinators and assistants within the Department. Supervision will ensure appropriate protocol assignment to other research staff, assuring training of research staff and nursing/physicians; monitoring of time allocation of effort; regulatory approvals; adherence to protocol guidelines; as well as assistance with federal, institutional, and departmental policies, and procedures. In addition, the Manager will serve as primary liaison for the Institute of Advanced Clinical Trials for Children and the Pediatric Trials Network (NIH). He/she will maintain open communication with physicians, nurses, advanced practitioners, fellows, and residents to ensure appropriate level of support for all research related activities. These duties will account for approximately fifty percent effort.

The remaining effort will be assigned as research coordinator for studies/trials in the division of Neonatology at Wake Forest Baptist and within the neonatal intensive care unit at Brenner Children’s Hospital and/or the Neonatal Follow-up Clinic. The Coordinator will help plan, recruit, consent, direct, educate, and implement studies as directed by the PI and/or Vice Chair including data entry, maintenance of patient logs, and completion of regulatory elements. He/she will develop strategies to promote enrollment of diverse populations and ensure regulatory compliance in accordance with federal, institutional, and departmental regulations.

JOB SUMMARY:

Under administrative review, provides overall administrative direction and coordination for policies, procedures, and programs for a large number of research studies and/or clinical trials. Supervises and provides expertise and guidance to staff regarding IRB submissions, communication, and implementation of HIPAA regulations, compliance and other regulatory issues. Requires the use of judgment and discretion in performing the assigned duties and responsibilities.

EDUCATION/EXPERIENCE:

Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or, an equivalent combination of education and experience. Experience in medical/research environment preferred.

Department Specific Desired Qualifications: A bachelor’s degree in a scientific field and/or nursing from an accredited Nursing School and a minimum of two years’ experience as a research coordinator. Master’s degree and work experience in pediatrics preferred.

LICENSURE, CERTIFICATION, and/or REGISTRATION: N/A

Department Specific Desired Qualifications: Certification as a Research Coordinator according to SoCRA/ACRP and completion of CITI Certification for Human Subjects Research required. Licensure as a Registered Nurse (RN) in the State of North Carolina if applicable.

ESSENTIAL FUNCTIONS:

1. Provides administrative direction and coordination in the formulation, interpretation and administration of current and long range policies, procedures, and programs across all clinical sites. Provides guidance and advice in the completion of initial and annual IRB approvals. Monitors the completion and approval of all IRB requests.

2. Ensures that all aspects of all studies are conducted in accordance to the applicable protocol and contract. Ensures that all HIPAA regulations, compliance and regulatory requirements are met. Acquires timely information regarding HIPAA privacy and security guidelines. Analyzes and determines the effect on the clinic activities and implement changes to maintain compliance with HIPAA and all other regulations, such as FDA, HHS, NIH, and OSHA. Participate in audits of cooperative groups and affiliates.

3. Manages a large clinical research staff including hiring, performance evaluations, merit recommendations, promotions, transfers, and schedules.

4. Monitors clinical functions and participant flow management. Develops procedures to ensure participant satisfaction and to maintain consistency throughout all clinics.

5. Directs the development of computerized methods for monitoring and reporting on research activities as well as the analysis of data. Assists principal investigators and project managers in developing progress reports and quality control monitoring.

6. Assists in protocol development activities, study operations, and closing of studies. Provides guidance to principal investigators in transitioning staff as funding begins/ends.

7. Establishes working relations with other departments and organizations and assists in integration of studies when appropriate. Facilitates and develops relationships with NIH, FDA, etc.

8. Provides guidance and oversight in determining how personnel, space, and equipment may be utilized across studies to improve efficiency. Plans and coordinates construction, renovation and maintenance activities within or related to the clinic.

9. Ensures that all requirements of the Medical School and the University comply to the conduct of the clinical research. Ensures that all technical requirements of the funding agency are met, including auditing requirements.

10. Coordinates and prepares operational reports and analyses setting forth progress, adverse trends and appropriate recommendations.

11. Participates and supports internal and external meetings and committees.
12. Assists in implementing institutional and departmental policies.

13. Manages special projects and other initiatives as assigned.

14. Performs other related duties incidental to work described herein.

SKILLS/QUALIFICATIONS:

• Excellent verbal and written communication skills
• Demonstrates knowledge of scientific and statistical principles
• Ability to travel to affiliate sites, clinical sites and national meetings
• Familiar with institutional/governmental regulations and guidelines related to clinical research including the elements of Good Clinical Practices

WORK ENVIRONMENT:
Clean, well lit, office environment

To apply for this position, please click on the "Apply Now" button on this page. You must complete the application process and then submit your application by clicking on the "Submit" button located at the bottom of the page titled "Submit Online Application". You will receive the following message once you hit the submit button: "You have successfully submitted your job application".

Computers are available for applying within the lobby of the Human Resources Department located at 1920 West First Street, (on the corner of Miller and First Street) Winston-Salem, North Carolina 27104. You may also call our office for assistance at (336) 716-6464. Office hours are Monday-Friday, 8:00am-5:00pm.

If you are an individual with a disability and need reasonable accommodation to participate in the application process, please contact our Supervisor of Office Services by phone (336) 716-3367 or email at accommodationrequest@wakehealth.edu.

It is the policy of Wake Forest Baptist Medical Center to administer all educational and employment activities without discrimination because of race, sex, age, religion, national origin, disability, sexual orientation, gender identity or veteran status (except where sex is a bona fide occupational qualification or a statutory requirement) in accordance with all local, state, national laws, executive orders, regulations, and guidelines.