Clinical Research Coord Inter

4 weeks ago

Ann Arbor, United States University Of Michigan Full time

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 Department of Surgery is seeking an experienced Clinical Research Coordinator (CRC) to assist with multiple study projects, in all aspects of clinical research including study planning, start up, IRB management, regulatory management, identifying and screening study patients, consenting and enrolling participants, study visit management, as well as data collection. This position continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Applicants who desire a team orientated atmosphere, who thrive on implementing new processes, and are interested in mentorship are encouraged to apply.

This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on the work of others.

Responsibilities*

The Clinical Research Coordinator (CRC) will be responsible for the meticulous conduct of both interventional and observational clinical research studies, including pharmaceutical, investigator initiated, cooperative group or industry sponsored trials. The CRC must be able to simultaneously integrate the workflow for multiple studies and will serve as a resource and contact person for active protocols. The CRC will be expected to facilitate communications between investigators, clinical staff, sponsors, contract research organizations, regulatory personnel, research patients, research support units, and study team members. This position also requires timely data entry, laboratory processing, accurate documentation, and the ability to work well within a team.

Clinical Coordinator Responsibilities: (ex. Develops processes, tools, and training to support related activities associated with study execution; Performs study procedures at the highest levels and mentors team members in accurate completion of study procedures; Develops processes and tools, and mentors study team in best practices for addressing subject concerns efficiently)

* Develops tools, processes, and training to enhance the administration and execution of clinical trials.
* Designs processes and tools to assess study execution and leads team on accurate implementation of protocol.
* Develops processes, tools, and training to support study execution
* Performs study procedures at the highest levels and mentors team members in accurate completion of study procedures.
* Develops processes and tools, and mentors study team in best practices for addressing subject concerns efficiently.

Data Coordinator Responsibilities: (ex. Oversees data quality; Performs at the highest level of data management and results reporting)

* Oversees data quality.
* Performs at the highest level of data management and results reporting.

Regulatory Coordinator Responsibilities: (ex. Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study; Oversees regulatory documentation for quality assurance; Develops processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products)

* Develops processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products.
* Monitors site compliance with subject safety reporting, escalates issues, and develops tools, processes, and training to enhance subject safety during the conduct of a clinical study.

Training: (ex. Provides training and mentorship of other clinical research staff on a range of communication and teamwork best practices; maintain certification)

* All training requirements of previous level.
* Develops and conducts training for staff and others.
* Attends and participates in all training assigned to this level.

Other job responsibilities include:

* Screening and enrollment of potentially eligible study patients;
* Meticulous coordination and completion of study visits and laboratory procedures;
* Shipping biological substances per federal regulations;
* Distribution and accountability of study medications;
* Preparation and maintenance of IRB submissions and other regulatory documents;
* Timely and accurate entry of data;
* Proficiency with collection and processing of laboratory specimens;
* Maintenance of studies in the OnCore clinical trial management system;
* Creation and maintenance of source documents for tracking, collection and recording of experimental data;
* Scheduling and completion of monitor visits, including timely completion of subsequent queries;
* Review of proposed research, billing calendars, and study budgets for input regarding feasibility and effort requirements;
* Creation of protocol summaries, checklists, workflow instructions, and other documentation to ensure proper and efficient study conduct;
* Assistance with multi-site contracts, including Material Transfer Agreements and Data Use Agreements;
* Interactions with committees, such as Investigational Drug Services and Inpatient Nursing, to develop study specific workflows that correlate with their requirements;
* Attendance at educational, investigator, and coordinator meetings;
* Maintenance of training, education, and knowledge regarding conduct of clinical research in accordance with federal and ICH GCP

Supervision Received: From Director of Clinical Operations

Supervision Exercised: Could provide Functional supervision ( likely in limited capacity such as training) of staff in titles within the CRC Career Ladder

Required Qualifications*

* Bachelors degree or equivalent combination of education and experience; Health Science preferred
* 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

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