Clinical Research Coordinator/ Patient Coordinator
Axle
Summary
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.
Job description
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.
Requirements
- Master's degree in psychology, social work, biological sciences, or a related discipline
- Minimum of three years of experience in a research-related field
- Minimum of one year of experience in behavioral counseling, preferably in drug, smoking, or alcohol treatment
- Basic Life Support (BLS) certification (training will be provided)
- 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
- Ability to complete all NIH/NIDA mandatory trainings and other required trainings by the deadlines set
- Microsoft Office
- Electronic medical records system
- REDCap
Benefits
- Medical, Dental & Vision
- Paid Time Off
- Paid Holidays
- 401(k) Matching
- Educational Benefits
- Employee Referral Bonus
- Healthcare FSA
- Parking Reimbursement
- Dependent Care Assistance
- Transportation Reimbursement
Company overview
Axle is a biotechnology research and technology services company founded in 2002 that specializes in accelerating discovery and enhancing organizational outcomes through innovative solutions. The company provides comprehensive research, technology, and healthcare services tailored to the dynamic needs of ambitious teams, particularly in the biomedical and public health sectors. Axle operates at the intersection of cutting-edge IT, artificial intelligence, machine learning, and extensive domain expertise, empowering organizations to meet current needs while shaping future standards. The company partners with major government agencies including the National Institutes of Health (NIH) and National Center for Advancing Translational Sciences (NCATS), delivering enterprise data platforms, AI/ML solutions, and advanced analytics capabilities that enable high-impact translational research at national scale. With a focus on healthcare authentication solutions, research informatics, and scientific computing, Axle helps organizations navigate the complexities of breakthrough research while ensuring compliance, data security, and operational efficiency across the healthcare and research continuum.