Clinical Research Coord II, Research Administration
About The Position
With minimal supervision, the Clinical Research Coordinator II (CRC-II) is responsible for providing coordinator support to multiple human subjects’ (clinical) research projects and is expected to perform all core Clinical Research Coordinator (CRC) responsibilities. Study management includes but is not limited to assessing feasibility of clinical research protocols, preparing materials needed for regulatory review and submission to the Institutional Review Board (IRB), identifying potential study participants, coordinating and collecting research data/specimens, completing study records in an accurate and timely manner, participating in quality assurance audits, managing study materials and supplies, communicating across multiple teams, and archiving records in accordance with appropriate policies and procedures. The CRC-II is the mid-level position in the Clinical Research Coordinator series.
Requirements
- Minimum three years of clinical research coordination experience.
- Associate degree or equivalent additional experience can be accepted in lieu of education.
- Basic knowledge of key Microsoft Office programs (Word, Excel, PowerPoint).
- Demonstrate strong interpersonal skills.
- Able to communicate effectively both orally and in writing.
- Be detail oriented.
- Able to work under pressure in a fast-paced environment while managing multiple competing priorities.
- Working knowledge of human subjects’ regulatory requirements, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines for Good Clinical Practice (ICH-GCP).
- RQI Responder- American Heart Association. If incumbent does not have certification at time of hire or promotion, certification is expected to be obtained within 6 months of assuming position. With management approval, the time in which to obtain certification may be extended past 6 months due to extenuating circumstances.
Nice To Haves
- Clinical research experience in a hospital setting and/or pediatric clinical research experience.
- Bachelor’s degree in a relevant field.
- Ability to conduct informed consent.
- Working knowledge of Cerner or equivalent electronic medical record system.
- Knowledge of sample identification, processing and storage.
- Phlebotomy certification.
- Association of Clinical Research Professionals Certified Professional (ACRP-CP), Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC).
Responsibilities
- assessing feasibility of clinical research protocols
- preparing materials needed for regulatory review and submission to the Institutional Review Board (IRB)
- identifying potential study participants
- coordinating and collecting research data/specimens
- completing study records in an accurate and timely manner
- participating in quality assurance audits
- managing study materials and supplies
- communicating across multiple teams
- archiving records in accordance with appropriate policies and procedures
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
Number of Employees
5,001-10,000 employees
