Job Description

Summary
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.

Does this position require Patient Care?
No

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 through 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 Related Field of Study required

Can this role accept experience in lieu of a degree?
Yes

Licenses and Credentials

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.

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

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.

Job Tags

Contract work

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