Clinical Research Coordinator II - RI Academic Affairs & Research Dev

With supervision the CRC will engage in the enrollment recruitment retention of research participants and other tasks as needed. The CRC will conduct clinical interviews for children and adults obtain mental health history and review reported suicidal ideation/behavior to determine if further intervention is indicated. They will work on projects focused on youth mental health including school-based programming. Travel to school research sites required. Bachelors degree in social science field and previous research experience or work in the mental health field preferred. Effective customer service communication organization and attention to detail required.

Typical hours: Mon-Fri 8a-4:30p one late day/week 12p-8:30p. Hours subject to change dependent on project needs.

• 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 (CRFs) and ensures CRFs 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 subjects 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.

• Associates 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 / Pulling: 61-100 lbs Sitting Standing Walking

CONTINUOUSLY: Audible speech Computer skills Decision Making Depth perception Flexing/extending of neck Hand use: grasping gripping turning Hearing acuity Interpreting Data Peripheral vision Problem solving Repetitive hand/arm use Seeing Far/near

(not specified)

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 individuals 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 their supervision. EOE M/F/Disability/Vet