Job Abstract

Market Range: 12

Hiring Salary: $5,014.28/Monthly

THIS IS A GRANT-FUNDED POSITION

JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Research Study Manager leads the coordination of research activities for the Division of Infectious Diseases in the Department of Pediatrics. This position supervises the Research Coordinators who enroll patients and obtain specimens and data for studies of respiratory infections including inpatients, patients in the emergency department and outpatients. This position works with research personnel at St. Jude to review and update SOPs, maintain study binders, process and ship specimens, ensure proper data entry, and deal with the Institutional Review Board.

DUTIES AND RESPONSIBILITIES:

1. Serves as clinical role model for research staff; plans, assigns, and oversees work assignments for research staff.
2. Assists with the orientation of new staff to research protocols.
3. Coordinates employees’ interactions with patients/clients and other departments as needed to accomplish project goals.
4. Maintains patient confidentiality using HIPAA Privacy Rule and HIPAA Security Rule guidelines. Complies with the Clinical Trials Unit Manual of Procedures (MOP).
5. Collaborates with the Principal Investigator (PI) to plan and monitor the recruitment timetable and enrollment.
6. Assures certification of project(s) staff and informs the PI of any non-compliance.
7. Implements study protocol and patient visit activities such that all protocol restrictions and requirements are met.
8. Reviews and maintains source documentation and case report forms for completion; ensures confidentiality of subject records.
9. Creates and maintains study logs for effective trial management.
10. Review consents and data collected for study subjects for each study visit.
11. Ensures study lab specimens for assigned project(s) are collected/sent in an appropriate manner.
12. Participates in conference calls as needed for assigned project(s) and disseminates information to clinic and administrative staff as necessary.
13. Completes and submits IRB renewals and the reporting of all serious adverse events. Maintain IRB documents and IRB communications in appropriate project critical documents binder.
14. Devises and implements protocols and data gathering methods such that all patients randomized to trials meet eligibility criteria.
15. Submits orders for supplies for assigned projects.
16. Assumes a leadership role in the absence of the PI.
17. Performs other duties assigned.

MINIMUM REQUIREMENTS:

EDUCATION: Bachelor’s Degree. (TRANSCRIPT REQUIRED)

EXPERIENCE: Four (4) years of experience in subject recruitment, informed consent, understanding of IRB requirements, following a research study protocol. OR Master’s Degree and two (2) years of experience in subject recruitment, informed consent, understanding of IRB requirements, following a research study protocol.

KNOWLEDGE SKILLS AND ABILITIES:

• Knowledge of study protocols to supervise, perform and carry out all study procedures.
• Ability to supervise and obtain informed consent and document the process according to policies of the UT IRB, Methodist Le Bonheur Healthcare, and St Jude Children's Research Hospital.
• Knowledge of IRB and other regulatory requirements and ability to maintain IRB approval.
• Skill to create/edit online case report forms in REDCap (with training) and enter and maintain data integrity.
• Ability to maintain contact with enrolled families to facilitate long-term follow-up.
• Ability to ensure quality and timely data collection and adherence to visit schedules.
• General computer skills including Microsoft Office especially Word and Excel.
• Ability to manage research coordinators.
• Good communication and management skills.
• Ability to respond to inquiries regarding numerous matters on a spontaneous basis.