Clinical Research Coordinator I - 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.

• 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 subjects 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 CRFs are completed prior to monitoring visits.
• Maintains regulatory binder and documents.

Associates degree STNA PCA LPN MA or equivalent work-related experience required. BA/BS preferred.

(not specified)

Ability to obtain CRA/CRC certification in a timely manner.

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.

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

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 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