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Michigan Medicine · 1 day ago

Clinical Research Coordinator - Assistant

Ann Arbor, MI

Full-time

Hybrid

Mid Level

3+ years exp

Michigan Medicine is one of the largest health care complexes in the world, dedicated to improving health through patient care, education, and research. They are seeking a Clinical Research Coordinator - Assistant to manage multiple clinical research studies, ensuring compliance with protocols and maintaining the integrity of data and specimen management.

EducationHealth CareMedical

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

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

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

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

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

Qualification

Clinical Trial ManagementRegulatory ComplianceData ManagementMedical TerminologyEClinical TechnologiesCommunication SkillsOrganizational SkillsProblem SolvingTeamwork

Required

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

Preferred

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

Benefits

Excellent medical, dental and vision coverage effective on your very first day

2:1 Match on retirement savings

Company

Michigan Medicine

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Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Maichigan.

Founded in 1869

Ann Arbor, Michigan, USA

10001+ employees