Clinical Research Coordinator Social & Behavioral Sciences I

Under the joint supervision of Drs. Mindy Westlund Schreiner and Lilian Li, this full-time post-baccalaureate position supports multiple NIMH-funded research projects aimed at identifying neural (e.g., EEG, MRI), behavioral, and digital markers (e.g., EMA, passive sensor data) of depression and self-injurious behaviors in adolescents. A one-year commitment is requested; a two-year or longer commitment is preferred.

Responsibilities

• Recruit and screen participants; collect data through clinical interviews, EEG tasks, EMA, passive sensor data, and online surveys.
• Manage elements of clinical studies to meet protocol obligations while following ICH/GCP guidelines and standard operating procedures, including start-up, launch, day-to-day management, and study closure activities.
• Recruit, consent, and enroll participants according to regulations and subjects’ rights through institutional IRB, federal, and state regulations, adhering to quality control guidelines and institutional standards.
• Collaborate, coordinate, and schedule subject study visits and research activities with hospital services, multidisciplinary teams, clinicians, statisticians, and community partners.
• Ensure inclusion and exclusion criteria are met; report safety issues, protocol deviations, or premature study termination requests.
• Conduct research visits, interviews, surveys, behavioral assessments, or other study procedures; answer questions related to protocol procedures and act as an advocate for participants.
• Assist with participant recruitment and retention strategies in clinical, hospital, or community settings.
• Collect, manage, and organize research data through database entry, data quality checks, and preparation of datasets for analysis.
• Organize subject information and create source documents to facilitate systematic data collection, protocol execution, management, and record keeping.
• Complete required study documentation, Case Report Forms (CRFs), or equivalent on time; maintain regulatory binders in accordance with institutional and sponsor requirements.
• Assist in drafting IRB materials, including protocols, consents, assents, and information sheets.
• Support investigators with literature reviews, reference library management, and preparation of manuscripts, abstracts, and presentations.
• Disseminate research findings through reports, publications, and presentations.
• Maintain lab website and documents; assist with IRB protocols and grants.

Requirements

• Associate's Degree, or equivalent certification or experience, required; Bachelor's Degree preferred.
• Certification as 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 a healthcare-related field preferred.

Skills

• Understanding of medical terminology and clinical research.
• Working knowledge of PCs, 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, fumes/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 0-40 lbs, machinery, patient equipment, pushing/pulling 0-100 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).