Clinical Research Specialist
About The Position
With principal investigator oversight, prepares, evaluates and implements research studies to enhance the advancement of clinical practice. Essential Functions 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 a variety of research studies with low or moderate regulatory, clinical, and operational complexity
- Evaluate and prepare 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
- Identify, recruit, screen, and enroll eligible subjects per protocol
- Monitor patient status; collects, reviews, and documents data into a variety of 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 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
- Communicate, collaborate, network, and act 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)
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, pet insurance
- Traditional and Roth retirement options with service contribution and match savings
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
