Clinical Research Associate II
About The Position
The Clinical Research Associate II works independently, with minimal direction and in close collaboration with clinical research coordinators, research program administrators, research nurses, and other supervising staff, to coordinate or implement increasingly complex research studies. The role supports study objectives through data collection, participant prescreening and scheduling, assistance with IRB submissions, budget and billing support, and compliance with federal and local guidelines. The associate also provides increasingly independent support by serving as a contact for sponsors, the IRB, and research participants; training and educating junior staff; and coordinating study-related ad hoc activities. The role may independently coordinate a small number of noncomplex research studies or projects.
Requirements
- High school diploma or GED.
- At least 1 year of clinical research-related experience.
Nice To Haves
- Bachelor's degree in science, sociology, or a related field.
- Clinical research certification, such as SOCRA or ACRP certification.
Responsibilities
- Coordinate or implement increasingly complex research studies under minimal direction from supervising staff.
- Collect, evaluate, abstract, and enter clinical research data; process data in sponsor-provided electronic data systems and complete Case Report Forms (CRFs).
- Assist with designing forms for data collection or abstraction.
- Independently prescreen potential research participants and schedule participants for research visits and procedures.
- Provide increasingly independent contact with research participants and, when appropriate, conduct participant visits independently.
- Assist supervising staff with submissions to the Institutional Review Board (IRB); may submit adverse events, serious adverse events, and safety letters directly to the IRB.
- Assist with clinical trial budgets and patient billing.
- Prepare and ship samples and maintain study supplies and kits.
- Ensure compliance with study protocols, research objectives, federal and local agency requirements, FDA requirements, and IRB requirements.
- Maintain research practices in accordance with Good Clinical Practice (GCP) guidelines and protect patient confidentiality in accordance with HIPAA and applicable law.
- Serve as the primary contact for external sponsors on selected trials, respond to sponsor inquiries, and attend meetings about study activities.
- Participate in and provide training and education to other Clinical Research Associates.
- May help coordinate other associates' activities to support protocol and research-objective compliance.
- Participate in centralized activities such as auditing and Standard Operating Procedure development.
- May participate in developing investigator-initiated trials for Investigational New Drug or Device applications.
- May independently coordinate a small number of noncomplex research studies or projects.
- May cover supervising staff's study coordination activities when needed to minimize disruption to study objectives.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
