Clinical Research Technician underfill Clinical Research Assistant

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

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

Clinical Coordinator Responsibilities

• Performs non-GCP related study management activities; Performs study procedures with minimal supervision; Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits; Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.)
• Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures.
• Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.
• Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
• Demonstrates accurate implementation of protocol procedures.
• Explains and performs study non-GCP related study management activities.
• Performs study procedures with minimal supervision.
• Triages simple subject concerns and issues appropriately.
• Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
• Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
• Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.

Data Coordinator Responsibilities

• Demonstrates the ability to document data in accordance with ALCOA-C principles; Completes complex data collection during study visits; Demonstrates ability to resolve data queries
• Demonstrates the ability to document data in accordance with ALCOA-C principles.
• Explains how to utilize information from the EMR and study databases.
• Completes complex data collection during study visits.
• Demonstrates ability to resolve data queries.

Regulatory Coordinator Responsibilities

• Form completion and reporting to external governing bodies such as the FDA; Demonstrating an understanding of the elements of subject safety, related documentation, and reporting; Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks
• Explains and performs study operational activities in compliance with Good Clinical Practice (GCP)
• Explains proper documentation techniques as outlined in the ICH-GCP guidelines.
• Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them.
• Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT.
• Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies.
• Collaborates with MIAP for INDs and IDEs.
• Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments.
• Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• Maintenance of updated regulatory documentation.
• Explain the investigational products development process and identify key regulations to control these processes

Administrative Responsibilities

• Provide other administrative support for study activity including management of subject reimbursement and payments
• May assist with creating posters, abstracts, and articles
• Participates in regular study meetings. Properly completes payment forms and pays participants accordingly

Training

• Participates in trainings specifically for certification as a Clinical Research Professional
• All training requirements of previous level.
• PEERRS, HIPAA, CITI GCP
• eRPM` Regulatory training
• Attends and participates in all training assigned to this level.

Technician Requirements:

• 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.
• Experience in a medical setting
• Previous experience with subject recruitment and retention, and coordination and management of clinical trials required.
• Experience in the regulatory aspect of clinical trial management.
• Ability to work independently or as a member of a team.
• Demonstration of understanding of Medical Terminology.
• 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.

Assistant Requirements:

• High school diploma or GED is necessary.
• Experience in a medical setting
• Previous experience with subject recruitment and retention, and coordination and management of clinical trials required.
• Experience in the regulatory aspect of clinical trial management.
• Ability to work independently or as a member of a team.
• Demonstration of understanding of Medical Terminology.
• 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.

Technician Desired Qualifications:

• Bachelor’s 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.

Assistant Desired Qualifications

• Associate 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
• 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.
• Certification through ACRP or SOCRA.
• 3+ Years of Clinical Research Experience.

Monday - Friday 8:00am-5:00pm (hybrid)

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

Continuation of research staff appointments is subject to performance that meets or exceeds the appointing unit and University criteria and the availability of continued funding.

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.

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

Supervision Exercised: None.