Clinical Research Specialist

Corewell Health • Grand Rapids, MI

1d • Onsite

About The Position

With principal investigator oversight, prepares, evaluates and implements research studies to enhance the advancement of clinical practice. May serve as primary coordinator / project manager on a variety of research studies with low or moderate regulatory, clinical, and operational complexity; supports the PI and research team members. Evaluates and prepares research studies for implementation including: assessment of operational feasibility; budget development; preparation of IRB documents; institutes protocol operations (generation of data collection tools, case report forms); attends study meetings. Identifies, recruits, screens, and enrolls eligible subjects per protocol; with appropriate training and delegation, performs protocol-required research activities and/or protocol-required research procedures with low clinical complexity (e.g. six-minute walk test, SF-36, etc.). With appropriate training and delegation, monitors patient status; collects, reviews, and documents data into a variety of systems per protocol. Maintains research studies in compliance with federal, state, and local law, GCP, contracts, and institutional policies. Coordinates and/or performs study activities which may include: identification of adverse events; assist with management of investigational product/test article (drug or device); collection, processing, and shipment of research specimens; and other research activities to the extent permitted by law and policy. Communicates, collaborates, networks, and acts as a consultant to the study sponsor and/or CRO, research study centers, academic institutions, investigators, physicians/physician offices, ancillary departments, and the multidisciplinary team (including students and residents).

Requirements

• Bachelor's Degree in health or science related field or equivalent
• CRT-Basic Life Support (BLS) - ARC American Red Cross 90 Days Or CRT-Basic Life Support (BLS) - AHA American Heart Association 90 Days

Nice To Haves

• 1 year of relevant experience in clinical research and project management

Responsibilities

• Serve as primary coordinator / project manager on research studies.
• Evaluate and prepare research studies for implementation.
• Assess operational feasibility of research studies.
• Develop budgets for research studies.
• Prepare IRB documents.
• Institute protocol operations, including generation of data collection tools and case report forms.
• Attend study meetings.
• Identify, recruit, screen, and enroll eligible subjects per protocol.
• Perform protocol-required research activities and/or research procedures with low clinical complexity.
• Monitor patient status.
• Collect, review, and document data into various systems per protocol.
• Maintain research studies in compliance with federal, state, and local law, GCP, contracts, and institutional policies.
• Coordinate and/or perform study activities such as identification of adverse events.
• Assist with the management of investigational product/test article.
• Collect, process, and ship research specimens.
• Communicate, collaborate, and network with study sponsors, CROs, research centers, academic institutions, investigators, physicians, ancillary departments, and the multidisciplinary team.

Benefits

• Comprehensive benefits package to meet your financial, health, and work/life balance goals.
• On-demand pay program powered by Payactiv
• Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!
• Optional identity theft protection, home and auto insurance
• Traditional and Roth retirement options with service contribution and match savings

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level