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Clinic 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.
Work Location: Minneapolis, Minnesota
Minimum Educational Requirements:
- Bachelor’s degree in health sciences or related field
- 2-years professional research experience as a Clinic Research Coordinator
- Completion of CITI Course
- Understanding of Category B shipping procedures
- Understanding of local HIPAA regulations
Preferred Additional Requirements:
- SOCRA or ARCP research compliance certifications
- Bachelor’s degree in Nursing (RN/LPN) and current licensure or Medical Assistant certification
- Reproductive Medicine or Infertility Clinic 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 laboratory experience. Ability to successfully recruit 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.
- Monitor budget expenses and billing for allied services; assist with payment schedule of fees for internal 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 and recruit subjects, Schedule visits, Answer subject inquiries, Oversee study visits, Liaison between participants and primary investigator/sub Pls/sponsor/monitor)
- Prepare for and coordinate site visits made by sponsor and/or federal agencies during and at close of study.
- Represent research site at scheduled meetings with NICHD if necessary.
- Prepare, submit and maintain of IRB, IND or other regulatory documents and research correspondence as necessary.
- Assist in development of educational materials and education of community/other research professionals regarding studies.
- Supervise, mentor and train new or junior research staff and research assistants.
- Coordinate with referring physicians to provide information regarding available research projects and maintain strong referral base.
- 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 and assess study protocol violations, submit protocol violation reports and request for protocol violation waivers.
- 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
Karen Rupprecht at 612-863-2697
Mail your resume and cover letter to:
Center for Reproductive Medicine
Attn: Karen Rupprecht
2828 Chicago Avenue South, Suite 400
Minneapolis, MN 55407-1320