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Clinical Research Coordinator

Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Axle is seeking a Clinical Research Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute on Drug Abuse (NIDA) located in Baltimore, MD.

Benefits We Offer:

• 100% Medical, Dental & Vision Coverage for Employees
• Paid Time Off and Paid Holidays
• 401K match up to 5%
• Educational Benefits for Career Growth
• Employee Referral Bonus
• Flexible Spending Accounts:
  • Healthcare (FSA)
  • Parking Reimbursement Account (PRK)
  • Dependent Care Assistant Program (DCAP)
  • Transportation Reimbursement Account (TRN)

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.

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.

The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com

This role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate's experience, qualifications, skills, and location.

Salary Range $100,000 $105,000 USD