Clinical Research Associate

Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research.
Essential Functions:
-Maintain and organize study-specific regulatory binders.
-Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
-Revise informed consent documents to include new risk information and/or updated protocol requirements throughout the course of the study.
-Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
-Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.
-Collect, complete, and submit essential regulatory documents to various regulatory entities.
-Participate in monitoring visits and maintain a record of all correspondence related to these visits.

Education:

• Bachelor's Degree in a Related Field of Study required

Experience:

• Research-Related Experience 1-2 years preferred

Knowledge, Skills and Abilities:

• Attention to detail.
• Ability to recognize compliance and data integrity issues and respond appropriately.
• Working knowledge of clinical research protocols.
• Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
• Effective interpersonal and communication skills.

The General Hospital Corporation is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.