Clinical Research Coordinator II - RI Gene Therapy

The Clinical Research Coordinator II is responsible for 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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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.

Knowledge, Skills & Abilities:

Education Requirement:

• BA/BS preferred; Associates degree or equivalent work-related experience

required.

• Certifications: CRA/CRC certification preferred.

Skills:

• 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.

Experience:

• Minimum of 18 months experience in clinical research or health care field, two years preferred.

Is driving required? Yes, depends

on position.

If yes, personal vehicle? Yes

Care provided in patient

homes?

Yes

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