The Clinical Research Coordinator’s primary responsibility is managing elements of clinical studies in order to meet all protocol obligations while following International Council on Harmonization of Technical Requirements/Good Clinical Practice(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.

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PRINCIPAL DUTIES AND RESPONSIBILITIES

Performs research activities as outlined in the protocol; implementing and organizing clinical research studies assigned to him/her which includes but is not limited to:

• Conducts clinical studies as outlined in the study protocol; performing study procedures according to recognized skill level and certifications and within the local and federal regulations and guidelines; adheres to good clinical practices. 
• 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. 
• Collects and controls research data and subject information; and maintains accurate data collection of all study data; including laboratory analytical procedures (if applicable). 
• Assists in the recruitment plan and the in cost estimation; manages screening sheets and recruitment logs, and 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
• Collaborates, coordinates, and schedules subject study visits with other hospital services and the PI/sub-I
• Enrollment of subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations
• Adheres to departmental quality control guidelines
• Ensures that the investigator verifies that the subject meets inclusion/exclusion criteria (prior to randomization for drug studies); verified that the subject and/or legal guardian has provided informed consent/assent; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate
• Assists PI in education of other study personnel with regards to study 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. 
• Completes Case Report Forms (CRFs) as instructed by the sponsor; ensures CRF’s are completed prior to monitoring visits.
• Responsible for regulatory/IRB issues after a study has been initiated; assists in maintaining regulatory binder. 
• Assists the principal investigator in the preparation of scientific publications and grant proposals. 
• Coaches and mentors new clinical research coordinators.
• Performs other duties and maintains flexible schedule as required by a protocol or unit needs, including, but not limited to: after-hours coverage and off-site NICUs.

KNOWLEDGE , SKILLS AND ABILITIES REQUIRED 

• Associates degree or equivalent work-related experience; BA/BS preferred. 
• 2 years’ experience in clinical research or health care field.
• Understanding of medical terminology and clinical trials preferred. 
• CCRC/CCRP/CRA certification beneficial or ability to obtain certification in a timely manner. 
• Valid driver’s license and insurance coverage to drive to off-site NICUs.
• Skills required:
  • Working knowledge of PCs and word processing and data management software Verbal and written communication
  • Goal-oriented; self-directive
  • Initiation, motivation, creativity 
  • Organizational and interpersonal 
  • Ability to actively participate as a team player 
  • Mentoring/training of new CRC’s MINIMUM

PHYSICAL REQUIREMENTS

• Talking on phone/in person
• Sitting
• Standing/Walking
• Lifts objects weighing up to 25 pounds
• Typing on keyboard

The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individual so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.

EOE M/F/Disability/Vet