Clinical Research Coordinator II - RI Academic Affairs & Research Dev

Davita Inc.; Columbus (OH); On-site; USD 55,000 - 70,000; Full time

Job summary

A leading healthcare company is seeking a Clinical Research Coordinator to engage in the enrollment and retention of research participants, conduct clinical interviews, and manage study activities. This role requires strong analytical and organizational skills to support youth mental health projects, including school-based programming, with a focus on following good clinical practices.

Qualifications

• Minimum of eighteen months experience in clinical research required.
• CRA/CRC certification preferred.
• Goal-oriented, self-directed with strong analytical skills.

Responsibilities

• Conducts clinical studies and ensures subject safety and adherence to protocols.
• Recruits and enrolls subjects according to guidelines and manages data collection.
• Coordinates subject study visits and communicates with the study team.

Skills

Medical Terminology

Clinical Trials

Data Management

Analytical Skills

Communication Skills

Organizational Skills

Teamwork

Education

Associate's Degree or Equivalent Work Experience

BA/BS Preferred

Tools

PCs and Word Processing Software

Data Management Software

Job description

Overview:

With supervision, the CRC will engage in 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 is required. A Bachelor's degree in a social science field and previous research experience or work in the mental health field are preferred. Effective customer service, communication, organization, and attention to detail are required.

Typical hours: Mon-Fri 8 am - 4:30 pm, with one late day/week from 12 pm - 8:30 pm. Hours are subject to change based on project needs.

Job Description Summary:

Manages elements of a clinical study to meet protocol obligations while following ICH/GCP guidelines and departmental/institutional standard operating procedures. Coordinates start-up activities, launch activities, day-to-day management of a study, and study closure activities. Trains and mentors other CRCs to ensure consistency in study management activities.

Essential Functions:

• Conducts clinical studies as outlined in the study protocol; ensures subject safety and adherence to good clinical practices.
• Recruits, consents, and enrolls subjects according to ICH/GCP regulations and IRB, federal, and state guidelines; ensures subjects meet inclusion/exclusion criteria; acts as a patient/family advocate.
• Coordinates and schedules subject study visits; manages protocol-required data; performs study procedures within recognized skill levels and regulations; collects, processes, and ships human specimens for research.
• Identifies study issues and collaborates with the study team to develop solutions to ensure progress and success.
• Assists with recruitment planning and provides input into the study budget; manages screening, enrollment, and participation logs; completes recruitment summaries at study end.
• Creates source documents for systematic data collection; conducts accurate and timely data collection.
• Assists with study database development; completes Case Report Forms (CRFs) prior to monitor visits.
• Educates study personnel on responsibilities and maintains documentation of training.
• Alerts investigators to safety concerns, protocol deviations, or premature study termination requests.
• Maintains regulatory binder and handles IRB issues post-study initiation.
• Assists in preparing scientific publications and grant proposals.

Education Requirement:

• Associate's degree or equivalent work experience required.
• BA/BS preferred.

Licensure Requirement:

Not specified

Certifications:

CRA/CRC certification preferred.

Skills:

• Understanding of medical terminology and clinical trials preferred.
• Proficiency with PCs, word processing, and data management software.
• Strong analytical skills with attention to detail.
• Excellent verbal and written communication skills.
• Goal-oriented, self-directed, capable of managing complex projects independently.
• Strong organizational and interpersonal skills.
• Team player with active participation skills.

Experience:

Minimum of eighteen months experience in clinical research or healthcare required.

Physical Requirements:

Occasional exposure to cold, driving, fumes, loud noises, reaching, squatting; frequent bending, lifting, pushing, pulling, sitting, standing, walking; continuous speech, computer use, decision-making, visual and auditory acuity, problem-solving, repetitive hand/arm movements.

Additional physical requirements are not specified.