About this role
Clinical Research Coordinator Intermediate
The Michigan Medicine Department of Anesthesiology is seeking an experienced, positive, highly motivated, organized, and independent individual with strong communication and multitasking skills to join our growing research team.
This position will support the Heart Study Data Collection II Study, an industry-sponsored research project focused on collecting data to support product development. The study will utilize commercially available devices to collect data from patients with a range of medical conditions and varying levels of disease severity.
In this role, you will be responsible for recruiting, screening, and obtaining informed consent from potential research participants for this study, as well as other studies within the department. You will communicate with participants by email and phone for a variety of study-related purposes, including recruitment, screening, scheduling study visits, troubleshooting study-related technology, and following up to support participant compliance and retention.
You will also collect clinical measurements from the electronic health record and/or medical devices, including blood pressure, vital signs, and other vascular health metrics, and accurately record this information in the appropriate data capture systems. This position may require travel between study sites to complete various research-related tasks.
Supervision Received:
This position reports directly to a CRC-Senior.
Responsibilities*
- Scientific Concepts and Research Design
- Ethical Participant Safety Considerations
- Investigational Products Development and Regulation
- Clinical Study Operations (GCPs)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication and Teamwork
In this role, you will be responsible for identifying, screening, and obtaining informed consent from potential research participants. You will communicate with participants by email and phone for a variety of study-related purposes, including recruitment and screening, scheduling study visits, troubleshooting study-related technology, and conducting follow-up to support participant compliance and retention.
You will be responsible for maintaining participant safety, monitoring and documenting adverse events, performing study testing, and acquiring study-related data. This role also requires maintaining data security and confidentiality and adhering to HIPAA regulations and all applicable institutional policies.
Additional responsibilities include entering research data into electronic data capture systems such as OnCore, MQUARK, SharePoint, REDCap, and MyDataHelps, as well as maintaining paper case report files when needed. You will assist in the creation and maintenance of study materials and data collection tools. You will follow standard operating procedures and use electronic tracking systems to monitor participant recruitment, enrollment, and retention. You may assist in preparation of reports or materials for meetings and presentations.
You will also utilize designated study hardware to perform study testing, ensure proper handling and use of study equipment, and maintain the physical security of all study hardware and related materials.
Required Qualifications*
Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent.
Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.
Interest in clinical health research
Excellent organizational skills and attention to detail
Superb interpersonal skills - comfortable speaking with healthcare providers and patients and working independently and as a member of a research team.
Ability to communicate effectively and professionally in both verbal and written form
Ability to communicate research study details clearly over the phone
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.
Collect and record participants study-related data.
Perform general office and administrative duties related to clinical studies.
Ability to adhere to established timelines to accomplish tasks.
Demonstrated ability to learn and use new skills quickly and effectively.
Desired Qualifications*
An understanding of medical terminology
Experience in interviewing research participants
High degree of comfort with smart phones, and other r