A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
The Program for Clinical Research in Dermatology (PCRiD) is seeking an experienced, positive, highly motivated, organized, autonomous individual with excellent communication and multi-tasking skills to join our growing research team. The Clinical Research Assistant will work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of dermatology clinical research studies. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities.
The Clinical Research Technician position's responsibilities include, but are not limited to the following:
- Screen, recruit, provide informed consent, and enroll participants according to protocol for clinical studies.
- Schedule participant study visits in coordination with laboratory and other clinical staff.
- Directly interact with subjects in a clinic setting including subject interviews, administering survey instruments, etc. and assisting with skin biopsies.
- Track and monitor participants? condition and test results during the course of clinical studies. Relay relevant
results to the clinical team. - Collect and record participants study-related data.
- Collect, process, label, store, and ship bio-specimens for clinical studies.
- Complete and document participant compensation according to requirements.
- Ensure all study related documentation is completed accurately with quality and in a timely fashion per sponsor requirements. May require data entry into both electronic and paper case report forms.
- Perform clinical study supply organization and clinic room preparation.
- Manage regulatory requirements including IRB submissions in eResearch Regulatory Management system, collection of essential regulatory documents, execution of study protocol, and preparation for sponsor monitoring visits.
- Perform medical chart reviews.
- Review billing calendars and study budgets to ensure appropriate care designations and costs for clinical studies.
- Work with administrative staff to ensure appropriate billing for study-related care.
- Design source documents, recruitment materials, and other relevant study documents for clinical studies.
- Attend investigator meetings as a study team member and participate in recruitment strategies to enhance subject awareness of studies and boost subject participation.
- Attend training at sponsor site(s) or during investigator meetings.
- Work collaboratively with PCRiD team members, including training, mentoring, cross-covering for other studies when needed, and attending staff meetings.
- Assist research team in generation of presentations, abstracts, posters and manuscripts.
- Perform general office and administrative duties related to clinical studies.
- Other duties deemed necessary to maintain the smooth operation of Dermatology clinical studies.
- Associate's degree in a relevant field of study and/or equivalent experience in a health sciences discipline
- ONE of the following:
- Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
- An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.
- Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
- Professional demeanor and excellent interpersonal and communication skills.
- Experience with Microsoft Office products (i.e. Microsoft Word, Excel, and Power Point)
- Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
- Outstanding organizational skills with meticulous attention to detail.
- Strong ability to work independently, exercising good judgement, with minimal supervision.
- Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner.
- Strong problem-solving skills.
- Ability to adhere to established timelines to accomplish tasks.
- Demonstrated ability to learn and use new skills quickly and effectively.
- Able to maintain data confidentiality and participant/subject/patient privacy.
- Excellent attendance record and strong work ethic.
- Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA regulations
- Bachelor or Master's degree
- Research experience including direct interaction with research patients in a patient care setting or outpatient
clinic - Some familiarity with REDCap, OnCore, Epic, MiCHART, and eResearch applications
- IRB/regulatory experience
Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Job openings are posted for a minimum of seven calendar days. The review and selection proce
