Clinical Research Coord Assoc - Ann Arbor, United States - University Of Michigan

Description

How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume.

The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Summary

The anesthesiology department is seeking a highly motivated and friendly individual to join the Michigan Perioperative Pain Research (MPR) team as a clinical research coordinator.

The MPR is a fast-paced, dynamic group that has several projects ranging from investigator initiated to sponsor funded (NIH, PCORI).

Emphasis is placed on maintaining a positive work environment, fostering comradery, and encouraging professional development. Our mission is to better understand the transition to acute to chronic pain, perioperative outcomes, and post-operative pain management.

This work will transform care, while dedication to our guiding principles enriches the lives of our team members and those in the community.

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.

Responsibilities*Independent knowledge, skills, and abilities within all 8 competency domains is expected:•Scientific Concepts and Research Design

• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Study Duties

• Oversee and complete all aspects of clinical study coordination including: identifying and screening potential subjects, consenting and enrolling subjects, and coordinating participant study visits/data collection.
• Serve as a resource and train research staff in performing specified job duties as specified by the project and/or program manager.
• Assist in developing improved work flows and source documents as needed.
• Maintain source documents for accurate tracking, collection and recording of data.
• Perform data collection and entry into study databases.
• Perform recruitment activities at on and off-site UM locations.
• Utilizes critical thinking skills to recognize and solve patient/participant problems.
• Achieve proficiency in working with study databases. Be able to run reports, enter participant data into CRFs, abstract data from the EHR, distribute surveys in a timely manner and correctly.
• Keep study correspondences and documents organized. Ensure changes are implemented in study procedures and workflows as needed.
• Assist in preparation of reports for meetings and slide material for data presentations as specified by the project and/or program manager.
• Assist with adherence to project timeline and milestones.

Regulatory Duties

• Ability to identify and expeditiously report Adverse Events (AEs) and Serious Adverse Events (SAEs) to the project manager, program manager and PI.
• Assist with IRB submissions as needed.
• Conduct data cleaning as specified in the study protocol.
• Attain an in-depth understanding of the study/grant protocols and objectives to assist with their successful implementation.

General/Miscellaneous

• Staff members are expected to work independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times.
• Other tasks as defined by project and/or program manager.

Required Qualifications*CRC-Assoc

• 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. (Please review eligibility criteria from SoCRA