JobDetails
Position Summary:
Promotes good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and guidance documents for the conduct of clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording, and maintaining data and source documentation. This role reviews technical operations ensuring that all processes, protocols & procedures are quality controlled & functioning up to standards. This role ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the applicable Institutional Review Boards (IRB’s), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
Qualifications:
Education:
Bachelor’s Degree in science or healthcare related field OR In lieu of degree 3+ years’ experience in/with clinical setting or research background.
License(s)/Certification(s):
Must possess and Maintain Certified Clinical Research Coordinator (CCRC) within 2.5 years or upon eligibility.
Must possess and maintain current Basic Life Support (BLS) certification within 90 days of hire/start date.
Knowledge/Skills/Abilities:
Required English Skills
Basic reading skills
Basic writing skills
Basic oral skills
Communication Skills
Ability to respond appropriately to customer/co-worker
Interaction with a wide variety of people
Maintain confidential information
Ability to communicate only the facts to recipients or to decline to reveal information
Ability to project a professional, friendly, helpful demeanor
Computer Skills:
Basic Skill
Word, Excel, Outlook, Microsoft Teams
Essential Functions:
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Carle Health participates in E-Verify and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization. | For more information: human.resources@carle.com.
Effective September 20, 2021, the COVID 19 vaccine is required for all new Carle Health team members. Requests for medical or religious exemption will be permitted.