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Michigan Medicine · 1 day ago

Clinical Research Coord Assoc

Ann Arbor, MI

Full-time

Onsite

Entry, Mid Level

2+ years exp

Michigan Medicine is seeking an experienced Clinical Research Coordinator to assist with multiple study projects within the Traumatic Brain Injury Program. The role involves coordinating clinical research studies, managing regulatory compliance, and ensuring effective communication with study staff and participants.

EducationHealth CareMedical

Responsibilities

Responsible for all aspects of research regulatory compliance, such as preparation/writing of IRB protocols for submission and maintenance (including the initial applications, amendments, scheduled continuing reviews, progress reports, safety reports, adverse event reports, etc.), while ensuring effective routine communication with the IRB

Create and maintain study standard operating procedures/protocols and research binders

Perform literature reviews

Completion of study tracking documentation accurately and in a timely manner

Create and routinely update project tracking systems

Communicate and consult with investigators and study staff to ensure alignment with research protocols and regulatory requirements

Responsible for all aspects of research study coordination: Identifying/pre-screening potential subject records to ensure they meet study inclusion criteria, screening potential subjects, consenting and enrollment (using a variety of methods), interviewing subjects, collecting relevant clinical and demographic data, and conducting phone call follow-up assessments

Coordination of specimen collection and storage

Monitor subjects for safety and compliance with protocols

Coordination/management of all daily study operations

May develop, design, and conduct one or more small or moderately complex research projects according to plan; reviews progress and evaluate results

Formulates research methods and suggests options for improving quality, identifies potential problems, recommends, and implements solutions

Consults with study staff to refine or adapt methodologies to fit research goals and specific aims

Collaborates in development of new techniques and procedures/protocols

Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality

Regular active participation in research meetings will be expected

This position will assist with research studies within the Michigan Medicine Department of Emergency Medicine

Due to the nature of our patient care, this position will routinely require covering some evening and weekend shifts

Cross training with other staff will be required

Additional work-related tasks, not specifically outlined above, will be required of the candidate

Qualification

Clinical Research CoordinationIRB ManagementData ManagementMicrosoft Software ProficiencyResearch Protocols KnowledgeREDCap ExperienceCommunication SkillsTeam CollaborationAttention to DetailSelf-Motivation

Required

Excellent interpersonal, oral, and written communication skills with exceptional attention to detail

Must be organized, efficient, self-motivated, and proficient in computer skills including Microsoft software applications

Ability to organize and manage multiple tasks/projects simultaneously, as well as prioritize and exercise good judgment

Ability to work independently with minimal supervision while maintaining effective collaborations and communication with a diverse team of individuals in a diplomatic, professional, collaborative, and effective manner

Candidate will be expected to prioritize multiple tasks, meet deadlines, and adhere to strict confidentiality policies

Must be comfortable working in the Emergency Department (following established protocols to facilitate social distancing and reduce COVID-19 transmission risks), interacting with diverse populations, and potentially discussing sensitive topics with study participants and families

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

Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and 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. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying

Associate degree in Health Science or an equivalent combination of related education and experience

ONE of the following: Minimum 1 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying. 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. 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

High school diploma or GED is necessary

Preferred

Previous clinical research experience, clinic/hospital/lab work or volunteer experience, and knowledge of the research protocols and processes are highly desired

The ideal candidate for this position will be able to work as a member of a collaborative team but have the ability to function independently with limited supervision after a period of on-boarding

Familiarity and experience with Epic, MiChart and eResearch applications. PEERS, regulatory compliance, IRB review and approval process

Experience with REDCap (Research Electronic Data Capture), Qualtrics or a similar data capturing system

Company

Michigan Medicine

Glassdoor4.0

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