Clinical Research Technician underfill CRC Assistant - Term Limited

Mission Statement

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.

Responsibilities*

BASIC FUNCTION AND RESPONSIBILITY
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the Clinical Research Technician position is required.
 

CHARACTERISTIC DUTIES AND RESPONSIBILITIES
Experience as part of a team with all 8 competency domains is expected. *

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

• Understands protocol structure and how to interpret study requirements to ensure study compliance.
• Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases.
• Demonstrates the ability to complete simple data collection during study visits.
• Enters data to complete forms (CRFs) on paper, databases, or Electronic Data capture (EDC).
• May administer minimal risk consents, surveys, and questionnaires.
• Performs simple study procedures with accuracy.
• Performs clerical duties, including, but not limited to, mailing and filing correspondence, calling patients and obtaining medical records. 
• Performs moderately complex study procedures with accuracy.
• Triages simple subject concerns and issues appropriately.
• Assesses studies for execution and troubleshoots potential implementation issues.
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
• Completes simple to moderately complex data collection during study visits.
• May work with CTSUs to reconcile financial accounts for study participants.
• Assists with local quality control efforts.
• May create a recruitment plan that addresses the needs of the study population and develop materials for IRB submission that will aid in recruitment
• May assist research coordinator in conduct of Site Initiation Visit (SIV); attends SIV
• May assist in and attends monitor visits and or audits.
• Ability to assist with regulatory aspect of clinical trial management.
• Prepare study procedure kits, shippers, CRFs, and requisition forms.
• Ability to work independently or as a member of a team
• Exceptional organizational and computer skills in Microsoft software applications.
• Ability to work with minimal supervision while maintaining productivity standards
• Demonstrated problem solving and conflict resolution skills.
• Ability to multi-task, work well under time constraints and meet deadlines. 
• Excellent interpersonal, collaborative, oral and written communication skills with exceptional attention to detail and exercise of good judgement.
• Perform other related duties as assigned.
• Understands importance of participant confidentiality and complies with HIPAA and U of M regulations
• Demonstrates professional behavior and ethical integrity through the applications of all established processes and procedures related to the ethical treatment of participants
• May work with Office of Research Compliance to create and post studies in ClinicalTrials.gov.
• May obtain the CTN number for eResearch applications.
• Completes simple to moderately complex CRFs.
• Can resolve simple to moderately complex queries (e.g., data error changed numerous values in EDC)
• May assist in CRF development for Investigator Initiated trials.

Regulatory Coordinator Responsibilities (ex. -  Submission and management of IRB applications; Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs) and report appropriately.)
 

• May complete new eResearch applications.
• May maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• May gather participant approval via informed consent.
• Prepares and participates in internal and external audits.
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information or Events (ORIOs), and understands how to report appropriately.

Administrative Responsibilities (ex. - Provide other administrative support for study activity including scanning, filing, etc. of research documents as well as preparing, processing, and shipping biospecimens.)
 

• Demonstrates understanding of the clinical research objectives associated with the program.
• May communicate with study participants such as sending study correspondence via mail or email.
• May schedule subjects for research visits and FU appointments.
• May check study calendar for completion of study procedures.
• May manage study supply inventory.
• May utilize documents and systems to track recruitment and retention of participants.
• May complete and activate postings (advertisements, flyers, etc.) independently.
• May work with regulatory support to maintain regulatory binder (CVs, MD licenses, lab certifications, IRB rosters, UM lab norms, etc.)

Training (ex. - Participates in training opportunities on Good Clinical Practices (GCP))
 

• All training requirements of previous level.
• PEERRS, HIPAA, CITI GCP
• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
• Willing to learn and use available technology and systems to accomplish job requirements.
• Understands the disease process per program.
• Attends and participates in all training classes assigned to this level. Assists with training activities of staff and others.

Additional duties as assigned.

Required Qualifications*

• An understanding of medical terminology
• Experience in a large complex health care setting
• Ability to effectively communicate with staff and faculty of all levels
• Knowledge of university policies and procedures is desirable. 
• Previous experience with spirometry testing and/or sputum induction desired, however on-site training is available. 
• Clinical experience with respiratory patients is highly desired.

Technician Requirements:

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

Assistant Requirements:

• High School diploma or GED is necessary.

Desired Qualifications*

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

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world's most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Work Schedule

Work Schedule: Hybrid 8:00 A.M. - 4:30 P.M.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Additional Information

SUPERVISION RECEIVED
This position received direct supervision and should report directly to a Clinical Research Coordinator Lead, Clinical Research Project Manager, Administrator, or Faculty Principal Investigator

SUPERVISION EXCERCISED
None

TERM LIMITED POSITION
This is a term-limited appointment. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

Background Screening

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.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled any time after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.