"Clinical Research Technician / Assistant (underfill)"

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.

This position may independently provide study coordination for simple and moderately complex clinical research studies. Seeking highly motivated, positive, organized, and autonomous individual. As a member of this team, you will collect primary data, schedule participants, assist with regulatory preparations, prepare data to be analyzed, along with addition responsibilities as needed.

Experience as part of a team with all 8 competency domains is expected:

• 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

Project Management

• Assist in creating policies and procedures
• 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 clinical setting administering survey instruments.
• Track and monitor participants, relay results to the clinical team.
• 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
• Track ongoing presentations, posters, manuscripts for multiple projects

Data Management

• Collect primary data (e.g., administer questionnaires, perform survey research)
• Collect and record participant study-related data.
• Collect, process, label, store study related products.
• Complete and document participant compensation according to requirements
• Perform data management such as creating a database, cleaning data, or merging datasets
• Entering research data and managing databases
• Maintaining accurate and detailed databases
• Ensure all study related documentation is completed accurately with quality and in a timely fashion per requirements. Electronic and/or paper data entry into case report forms
• Maintain confidentiality and protect the privacy of others.
• Continue to maintain certifications and continuing education

Data Analysis

• Prepare data to be analyzed by study coordinators
• Assist in data processing
• Conduct preliminary data analysis

Research

• Preform clinical study supply organization and clinic room preparation.
• Consenting research study subjects
• Work with IRB adverse event reports
• Act in accordance with all relevant human subject regulations, identify potential protocol problems and, in collaboration with the PI, work to resolve those problems.

Supervision Received: This position receives direct supervision and reports directly to (Faculty Principal Investigator).

Supervision Exercised: None

Technician Level:

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. or 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. or 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.

Assistant Level:

• High school diploma or GED is necessary.

Both:

• An understanding of medical terminology, experience in a large complex health care or large corporation setting, ability to effectively communicate with staff and faculty of all levels, and awareness of policies and procedures
• Experience and understanding of clinical research or clinical trials
• Experience with personal information up to and including protected health information
• Experience of participating in the writing or editing of manuscripts and progress reports
• Demonstrated good judgment and strong problem-solving skills
• Familiarity with database systems and entry including one or more of the following: Oracle, REDCap, OnCore, Epic, MiChart, and eResearch applications.
• Proven experience in administering regulatory requirements and protocols

An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

Technician Level:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable.

Assistant Level:

• Associate Degree in Health Science or an equivalent combination of related education and experience is desirable.

Weekdays day shift. Alterations to this schedule may be required as the Principal Investigator deems necessary.

This position may be underfilled at the CRC-Assistant title based on selected candidates’ qualifications.

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.