Position Overview

The Clinical Research Coordinator will support NIDA's clinical research operations. The role involves screening and scheduling study participants, obtaining informed consent, and administering mental health assessments and diagnostic interviews. The coordinator will also collect and manage research data, maintain regulatory documentation, and serve as a liaison between participants and investigators. The role involves extensive participant contact, including the collection and handling of biological specimens. The work schedule may include weekends and nights. Candidates must have a Master's degree in psychology, social work, biological sciences, or a related discipline. They also need a minimum of three years of experience in a research-related field and a minimum of one year of experience in behavioral counseling, preferably in drug, smoking, or alcohol treatment. Basic Life Support (BLS) certification is required, and training will be provided.

Additional Qualifications

Certifications & Licenses

• Basic Life Support (BLS) certification (training will be provided)

Field of Study

• Masters Degree in Psychology, Social Work, or Social Sciences - Required 

• LMSW - Preferred

Software

• Microsoft Office

• Electronic medical records system

• REDCap

Skills

• Minimum of one year of experience in behavioral counseling, preferably in drug, smoking, or alcohol treatment - Required 

• Minimum of three years of experience in a research-related field

• Previous experience interacting with human subjects in a clinical or research setting

• Previous clinical trial work

• Excellent analytical, organizational, and time management skills

• Strong oral and written communication skills

• Exceptional interpersonal skills, with a customer service-oriented and client-focused approach due to extensive participant contact

• Ability to complete all NIH/NIDA mandatory trainings and other required trainings by the deadlines set

Deliverables

• Work products and documents related to administering mental health assessments and diagnostic interviews — Ad-Hoc

• Work products and documents related to obtaining participant medical and drug use information according to protocol criteria — Ad-Hoc

• Work products and documents related to obtaining informed consent documentation from participants in the screening protocol — Ad-Hoc

• Work products and documents related to follow-up correspondence with study candidates on recruiting status — Ad-Hoc

• Work products and documents related to arranging travel and distributing remuneration for study candidates — Ad-Hoc

• Work products and documents related to phone screen scripts, in-person screening appointments, and communications with study candidates — Ad-Hoc

• Work products and documents related to data entry in the electronic medical record system, generating reports, performing study procedures, processing and destroying specimens as needed, and maintaining storage records and inventory of biological specimens — Ad-Hoc

Statement of Work Details

• Assist in preparing and submitting accurate source documents related to all research procedures for review.

• Participate in developing and maintaining research protocol documentation and operations.

• Assist researchers with study testing, observations, data entry, and other duties associated with study sessions.

• Support clinical staff in developing, implementing, and maintaining clinical research data files and materials.

• Acquaint participants with the magnetic resonance imaging (MRI) or mock MRI scanner to assess their comfort level, fit, and eligibility to participate in MRI studies.

• Perform psychiatric evaluations.

• Collect research data and prepare information for input and analysis, including verifying study participant information and collecting testing data and results.

• Assist staff in developing and assembling related documentation and maintaining regulatory binders for all protocols.

• Perform accurate and timely data analysis, report results and findings, and respond to sponsor queries.

• Set up, format, and enter data into spreadsheets to analyze information and create reports.

• Enter data into research databases, systems, and applications for ongoing studies.

• Support the development of forms and questionnaires, assisting researchers in developing, maintaining, and completing study data collection forms and source documents.

• Review draft protocols, case report forms, and manuals of operations for clarity and completeness.

• Work with staff to design, develop, and prepare documents such as spreadsheets, letters, rosters, agendas, presentations, and meeting minutes or summaries.

• Support the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.

• Assist staff in screening prospective study participants and scheduling participants for research visits and procedures.

• Schedule and coordinate outpatient and inpatient visits, diagnostic studies, and medical tests.

• Assist researchers with the collection and analysis of research data and samples.

• Monitor participants' progress and serve as a liaison between study participants and investigators regarding any problems or adverse events, including out-of-range vital signs.

• Support the assembly, development, and review of new research projects.

• Assist key research personnel in ensuring clinical research activities are performed in accordance with federal, state, and institutional regulations, policies, and procedures.

• Assist researchers in planning and coordinating the initiation of research study protocols and implementing operating policies and procedures.

• Assist researchers in developing and maintaining current and new research protocols.

• Support the creation and management of clinical websites and web-based tools, collaborating with information technology (IT) staff to update a variety of websites.