Clinical Research Coord Assoc

Responsibilities

• Understanding of protocol elements/requirements
• Executing study procedures
• Anticipating and mitigating the potential for protocol non-compliance
• Accurate implementation of protocol procedures
• Describing and performing routine study management activities
• Performing study procedures with minimal supervision
• Triaging routine participant concerns and issues appropriately
• Scheduling, assisting with preparation, and attending study-related meetings (e.g. study initiation meetings, audits, monitoring visits, or community-based organizational meetings)
• Participating in regular study meetings
• Properly completing payment forms and pays participants accordingly
• Serving as primary point of contact for study and/or a study team
• Documenting data in accordance with ALCOA-C principles and/or the study data management plan
• Completing complex data collection during study visits
• Resolving data queries
• Appropriately identifying and reporting adverse events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs)
• Maintaining essential documents as outlined in the GCP guidelines, or other relevant guidelines
• Other related duties as assigned

Preferred

• * 4+ years of direct related experience
• 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

Benefits

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings
• Glassdoor
• 4.1
• 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 Michigan.
• Ann Arbor, Michigan, USA
• http://www.uofmhealth.org/
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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](https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Facrpnet.org%2Fcertification%2Fcrc-certification%2F&data=05%7C02%7Ceddimaur%40med.umich.edu%7C207bca1245074af8f7bd08dbfcc0890b%7C1f41d613d3a14ead918d2a25b10de330%7C0%7C0%7C638381676135659307%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJBTiI6Ik1haWwiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwi%2C%22ANiIsIk1haWwiXQ%3D%3D%7C3000%7C%7C%7C&sdata=e0KetBVQTzNN7t00uD8GMm4WIdwLcjndu%2BuAG0yzfLM%3D&reserved=0)) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association ([SOCRA](https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.socra.org%2Fcertification%2Fccrp-certification-exam%2Fcandidate-eligibility%2Fhttps%3A%2F%2Fwww.socra.org%2Fcertification%2Fccrp-certification-exam%2Fcandidate-eligibility%2F&data=05%7C02%7Ceddimaur%40med.umich.edu%7C207bca1245074af8f7bd08dbfcc0890b%7C1f41d613d3a14ead918d2a25b10de330%7C0%7C0%7C638381676135659307%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJBTiI6Ik1haWwiLCJBTiI6Ik1haWwiXQ%3D%3D%7C3000%7C%7C%7C&sdata=fmReyzK9xmrtAKQtWqPxoZ0JzFDP15TNfOIZcPXeoOY%3D&reserved=0)) as a Certified Clinical Research Professionals (CCRP) or equivalent
• Candidates must be eligible to **register or take the exam** at date of hire
• the certification must be **completed or passed etc**. within six months of date of hire
• * Minimum 2 years of directly related experience in clinical research and clinical trials is necessary
• Independent knowledge, skills, and abilities within all 8 competency domains is expected:
• Coordinator experience and mastery of all job duties from the CRC-Technician position on the [Michigan Medicine CRC Career Ladder](https://research.medicine.umich.edu/our-units/clinical-trials-support-office/clinical-research-coordinator-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
• The certification must be **completed or passed etc**. within six months of date of hire
• * 4+ years of direct related experience
• 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
• * Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.

Required skills

• ACRP Certified Clinical Research Coordinator (CCRC), Clinical Practice (GCP), Clinical Research, Clinical Study Operations, Clinical Trials, Data Management, Medical Terminology, SOCRA Certified Clinical Research Professional (CCRP)

Preferred skills

• * 4+ years of direct related experience

Experience

• 2+ years