Clinical Research Coordinator Social & Behavioral Sciences I

About the Role

Manages elements of a clinical study to meet all protocol obligations while following ICH/GCP guidelines and standard operating procedures. Includes start-up activities, launch activities, day-to-day management, and study closure activities.

Responsibilities

• Recruits, consents, and enrolls according to regulations and subjects’ rights through institutional IRB, federal, and state regulations, while adhering to quality control guidelines and institutional standards.
• Collaborates, coordinates, and schedules subject study visits and research activities with other hospital services, multidisciplinary teams, clinicians, statisticians, and community partners.
• Ensures inclusion and exclusion criteria.
• Alerts related to safety issues, protocol deviations, or premature study termination requests.
• Conducts research visits, interviews, surveys, behavioral assessments, or other study procedures.
• Answers questions related to protocol procedures as applicable and acts as an advocate.
• Assists with participant recruitment and retention strategies in clinical, hospital, or community settings.
• Collects, manages, and organizes research data through database entry, data quality checks, and preparation of datasets for analysis.
• Organizes subject information and creates source documents that facilitate systematic data collection that aid in protocol execution, management, and record keeping.
• Completes required study documentation, Case Report Forms (CRFs) or equivalent study documentation on time and maintains regulatory binders in accordance with institutional and sponsor requirements.
• Assists in drafting IRB materials, including protocols, consents, assents, and information sheets.
• Supports investigators with literature reviews, reference library management, and preparation of manuscripts, abstracts, and presentations.
• Disseminates research findings through reports, publications, and presentations.

Requirements

• Associate's Degree, or equivalent certification or experience, required.
• Bachelor's Degree, preferred.
• CNA, PCA, LPN, MA, or equivalent education or experience, required.
• Clinical Research Associate or Clinical Research Coordinator certification, preferred.
• Previous experience in clinical research or health care related field, preferred.

Skills

• 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.

Physical Requirements

• 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