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Clinical Research Coordinator - Minneapolis
Center for Reproductive Medicine (CRM) is a premier 5 physician reproductive endocrinology clinic specializing in the comprehensive evaluation and treatment of infertility. We have provided thousands of couples with “every conceivable chance of success” by realizing their dream of having a family. We are participating in a research initiative with a number of facets that will evolve over time.
We are currently seeking a Clinical Research Coordinator to oversee research studies in an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. This individual will coordinate and perform patient care procedures, data collection and source documentation.
The Clinic Research Coordinator will be working with both male and female participants, the NICHD, the University of Utah and the Center for Reproductive Medicine on a multicenter randomized clinical trial. Understanding of Good Clinical Practices, FDA, HIPAA and IRB regulations are expected; an understanding of research procedures and the ability to function independently is essential.
This person needs to be enthusiastic, have excellent people skills, be a self-starter with a strong work ethic, able to work alone as well as with others, troubleshoot, willing to educate other staff and be dependable.
Work Location: Minneapolis, Minnesota
Mininum Educational Reqiurements:
- Bachelor’s degree in health sciences or related field
- 2-years professional research experience as a Clinical Research Coordinator
- Completion of CITI Course
- Understanding of Category B shipping procedures
- Understanding of local HIPAA regulations
- Strong phlebotomy skills
Preferred Additional Requirements:
- Current RN license
- SOCRA or ARCP research compliance certifications
- Reproductive Medicine or Women’s Health experience
Working knowledge and past experience with patient scheduling, chart abstraction and medical record retrieval.
Understanding and experience with clinical trials research, source documentation, study oversight, and research staff oversight.
Phlebotomy and basic laboratory processing and biospecimen storage experience.
Ability to successfully recruit, enroll and retain participants in clinical trials.
- Strong people and communication skills, a positive attitude and able to work well with other professionals and patients.
- Oversee compliance to protocol; manage quality control, completion and submission of study related documentation and preparation of study site specific reports.
- Assist with monitoring of budget expenses and billing for allied services.
- Monitor enrollment goals and initiate strategies to promote enrollment and participant compliance.
- Coordinate and perform responsibilities related to research participants including: Determining subject population availability, Obtain informed consent and screening materials, Screen, recruit and enroll participants from clinic patient population, Schedule visits, Answer subject inquiries, Oversee study visits, Liaison between participants, investigators, sponsor, clinicians and monitors.
- Set up and coordinate monitor and sponsor site.
- Participate in training and steering committee meetings as needed.
- Prepare for and coordinate site visits made by sponsor and/or federal agencies during and at close of study.
- Maintenance of site compliance, regulatory and IRB documents.
- Supervise, mentor and train new or junior research staff and research assistants.
- Assist in coordination and development of outreach materials for referring clinicians, providing information and referral opportunities.
- Develop and maintain patient database, investigational logs and drug accountability logs
- Manage biospecimen collection, processing, storage and shipment.
- Maintain and assess subject health and safety during the course of the study.
- Prepare Adverse Event reports and provide ongoing follow-up and outcome data.
- Identify, assess and submit protocol violations and waiver requests.
- Some travel may be required for training purposes.
To Apply: Email your resume and cover letter to email@example.com
Fax your resume and cover letter to the attention of
Denise Lamb at 801/585-3332
Mail your resume and cover letter to:
University of Utah, School of Medicine
Attn: Denise Lamb, RN, Coordinator FAZST
30 North 1900 East, Room 2B200
Salt Lake City, Utah 84132
Please be prepared to provide 3 professional references