Research Coordinator

Date Posted: August 9, 2019
Reports to: Director of Clinical Operations
Location: Mercy Hospital
Job Status/Hours: Full time

SUMMARY STATEMENT:
This position is responsible for overseeing research studies, enrolling patients, coordinating timeliness for IRB submission, and preparing submissions for IRB sponsor regulatory requirements.

MAJOR AREAS OF ACCOUNTABILITY:
1. Track progress relating to research department compliance
2. Maintain, review, and revise department policies
3. Coordinating timeliness of IRB & SPA submission including but not limited to new study application, review of active studies, report adverse events and other required reporting
4. Prepare submissions for IRB or sponsor regulatory req. new study application, informed consent, track SAE/AE for trials
5. Sponsor/Regulatory binder – filing of incoming memos and correspondence, copying, responding to correspondence, maintain lab compliance, regulatory binders updating with PI and sub investigator license and current vitas
6. Annual continuing reviews of active studies
7. Screen, consent, and randomize potential patients, ongoing query resolution
8. In-service and supervise protocol compliance
9. Coordinate monitor visits
10. Study contact for patients and referring physicians
11. Contact evaluation and negotiations with sponsor
12. Attendance at investigator meetings
13. Time sensitive follow-up visits/tests/procedures for most patients
14. Close out of studies involving monitor visits, reconciling, all documentation and CRF’s

EMPLOYMENT SELECTION CRITERIA:
1. Current RN degree, or an LPN or CMA with research experience including study start up, IRB submissions, and SIVs
2. Previous research & IRB experience is preferred
3. Cardiovascular experience is preferred
4. Excellent communication, independent thinking and problem solving skills
5. Must be detailed oriented with ability to see the “big picture”

6. Flexible to change in a fast paced growing research department
7. Strong organizational skills
8. Must possess ability to collaborate with physicians, hospitals and study sponsors
9. Knowledge of GCP (Good Clinical Practice) and CFR (Code of Federal Regulations)
10. Demonstrated strengths in the following competencies:

Patient Focus Composure
Integrity and Trust Humor
Interpersonal Savvy Standing Alone
Problem Solving Time Management
Action Oriented/Priority Setting Communication (written and verbal)
Change Resilient/Personal Learning Intellectual Horsepower

To apply, submit your resume to HumanResources@mhvi.com

As an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, veteran or disability status.