The Clinical Research Coordinator II’s primary responsibility is managing all of the 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. The CRC II also trains and mentors other CRC’s to ensure consistency in study management activities.

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PRINCIPAL DUTIES AND RESPONSIBILITIES:

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

• 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
• Develops 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,
• Develops study database 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 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.
• Trains and mentors other clinical research coordinators.
• Performs other duties and maintains flexible schedule as required by a protocol or unit needs.

KNOWLEDGE , SKILLS AND ABILITIES REQUIRED

• BA/BS preferred; Associates degree or equivalent work related experience required;
• Minimum of 2 years of experience in clinical research or health care field.
• Understanding of medical terminology and clinical trials preferred.
• CRA/CRC certification preferred.

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; frequently (34-100%)
• Sitting; frequently (34-100%)
• Standing/Walking; frequently (34-100%)
• Lifts objects weighing up to 25 pounds; occasionally (0-33%)
• Typing on keyboard; occasionally (0-33%)

 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.