Research Coordinator
Date Posted: February 27, 2023
Reports to: Research Lead
Location: MHVI, Mercy Hospital campus (Coon Rapids, MN)
Job Status/Hours: 0.8 – 1.0 FTE, 32-40 hours per week
SUMMARY:
This position is responsible for overseeing research studies, enrolling patients, coordinating timeliness for IRB submission, and preparing submissions for IRB sponsor regulatory requirements.
RESPONSIBILITIES:
- Track progress relating to research department compliance
- Maintain, review, and revise department policies
- 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
- Prepare submissions for IRB or sponsor regulatory req. new study application, informed consent, track SAE/AE for trials
- 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
- Annual continuing reviews of active studies
- Screen, consent, and randomize potential patients, ongoing query resolution
- In-service and supervise protocol compliance
- Coordinate monitor visits
- Study contact for patients and referring physicians
- Contact evaluation and negotiations with sponsor
- Attendance at investigator meetings
- Time sensitive follow-up visits/tests/procedures for most patients
- Close out of studies involving monitor visits, reconciling, all documentation and CRF’s
EMPLOYMENT SELECTION CRITERIA:
- Current RN degree or medical research experience including study start-up, IRB submissions, and SIVs
- Previous research & IRB experience is preferred
- Cardiovascular experience is preferred
- Excellent communication, independent thinking and problem-solving skills
- Must be detailed oriented with ability to see the “big picture”
- Flexible to change in a fast-paced research department
- Strong organizational skills
- Must possess ability to collaborate with physicians, hospitals and study sponsors
- Knowledge of GCP (Good Clinical Practice) and CFR (Code of Federal Regulations)
- 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 |
MHVI offers a full benefit package, including:
– Competitive pay
– Employer HSA contribution
– 401k profit sharing and ongoing contribution – no employee contribution needed
– PTO plus paid holidays
– Medical insurance, including access to free online/at-home care
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.