Clinical Research Coordinator II- Research GI

Job Description

Summary:

Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start‑up activities, launch activities, day‑to‑day management of a study, and study closure activities. Trains and mentors other CRC’s to ensure consistency in study management activities.

Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start‑up activities, launch activities, day‑to‑day management of a study, and study closure activities. Trains and mentors other CRC’s to ensure consistency in study management activities.

• Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices.
• Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations;
  Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate;
• Coordinates, and schedules subject study visits with other hospital services and the PI/sub-I; manages protocol required data; performs study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; collects, processes and ships human specimens for use in research studies
• Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success
• Assists with the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination.
• Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; and conducts accurate and timely subject data collection,
• Assists with study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF’s) and ensures CRF’s are completed prior to monitor visits.
• Educates other study personnel with regards to study-specific responsibilities and keeps written documentation of this training.
• Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
• Responsible for regulatory/IRB issues after a study has been initiated; maintains regulatory binder.
• Assists the principal investigator in the preparation of scientific publications and grant proposals.

• Associate's degree or equivalent work-related experience, required.
• BA/BS, preferred.

(not specified)

CRA/CRC certification, preferred.

• Understanding of medical terminology and clinical trials preferred.
• Working knowledge of PCs and word processing and data management software.
• Demonstrated analytical skills with accuracy and attention to detail.
• Excellent verbal and written communication skills.
• Goal‑oriented and self‑directive, ability to manage complex projects independently.
• Strong organizational and interpersonal skills.
• Ability to actively participate as a team player.

Eighteen months experience in clinical research or health care field, required.

OCCASIONALLY:
Cold Temperatures, Driving motor vehicles (work required)
* additional testing may be required, Fume /Gases /Vapors, Loud Noises, Reaching above shoulder, Squat/kneel. FREQUENTLY:
Bend/twist, Biohazard waste, Blood and/or Bodily Fluids, Chemicals/Medications, Communicable Diseases and/or Pathogens, Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Lifting / Carrying: 21-40 lbs, Machinery, Patient Equipment, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Pushing / Pulling: 41-60 lbs, Pushing /…