Clinical Research Coordinator I

 

The Center for Surgical Outcomes Research (CSOR) seeks an energetic and collaborative applicant to serve as a Clinical Research Coordinator (CRC). The CSOR is part of the Center for Child Health Equity and Outcomes Research (CCHEOR) at the Abigail Wexner Research Institute at Nationwide Children’s Hospital. CSOR is a national leader in clinical and health services research related to the surgical care of children. CSOR provides a comprehensive research program that employs a wide range of methodologies to perform rigorous clinical and health services research. The desired CRC will serve alongside a multidisciplinary team of surgeons, biostatisticians, epidemiologists, research staff, and research trainees to improve the delivery and outcomes of surgical care for children.

 

 

Manages elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities.

 

 

Essential Functions:

• Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
• Ensures that the subject meets inclusion/exclusion criteria; alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
• Collects and manages research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures.
• Prepares and processes human specimens for use in research studies. Collects blood, urine, and other samples as needed according to skill level and certifications. Performs CLIA waived laboratory assessments. Such activities may be performed independently and may require evening and weekend hours.
• Completes screening sheets and recruitment logs.
• 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.
• Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I.
• Adheres to departmental quality control guidelines.
• Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits.
• Maintains regulatory binder and documents.

Education Requirement:

• Associate's Degree, or equivalent certification or experience, required.
• Bachelor's Degree, preferred.

Certifications:

• CNA, PCA, LPN, MA, or equivalent education or experience, required.
• Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) certification after hire, required.

Skills:

• Understanding of medical terminology and clinical research 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
• Strong organizational and interpersonal skills.
• Ability to actively participate as a team player.

Experience:

Previous experience in clinical research or health care related field preferred.

Physical Requirements:

OCCASIONALLY: Cold Temperatures, 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 / Pulling: 61-100 lbs, Sitting, Standing, Walking

CONTINUOUSLY: Audible sp