Clinical Protocal Coordinator

(ID: 2024-5984)

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 Protocal Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Mental Health (NIMH) located in Rockville, 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)

Overall Position Summary and Objectives

The Translational Immunopsychiatry Unit (TIU) is seeking an ambitious, conscientious, organized, and detail-oriented Clinical Research Coordinator (CRC) with strong interpersonal and communication skills to join our growing team at the National Institutes of Health (NIH). This CRC position will be supporting the National Institute of Mental Health (NIMH), located in Bethesda, MD. The primary responsibilities for this full-time on-site CRC position will be to provide clinical and biospecimen research coordination for the TIU and affiliated programs, including the Autoimmune Brain Disorders Program (ABDP).

Deliverables:

• Work products related to assist with subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, consent, and assent. - Daily
• Work products related to The TIU has one (1) active IRB protocol, a secondary use protocol for biomarker discovery in blood and CSF. The TIU has one (1) secondary use remote biospecimen collection protocol that is under scientific review. This protocol will allow for the enrollment of surplus biospecimens that are no longer needed for clinical testing. - Daily
• Work products related to supervision of biospecimen pick-up and transport - Biospecimens collected at the NIH will be transported from the site of the clinical encounter to the NINDS BCR. The CRC will establish SOPs for biospecimen transport and supervise post-bac IRTAs, who will be responsible for physically transporting the biospecimen. - Daily

Work Details:

• Update biospecimen management systems data systems SOPs as needed in the TIU Handbook. 1
• Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations. 2
• Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations. 3
• Supports clinical staff develop, implement and maintain clinical research data files and materials.
• Prepare new IRB protocols for submission. Scientific writing will be handled by the study investigators
• Serve as point of first contact for inquiries from the IRB.
• Monitor and prepare reports on recruitment and enrollment status. Schedule and participate in monitoring and auditing activities and coordinate responses to audits.
• Collects research data and prepares information for inputs and analysis.
• Assist clinical and research staff to ensure that study and regulatory forms are completed and submitted on time to IRB and regulatory bodies
• Supports the development of forms and questionnaires.
• Review collaborator/participating organization IRBs for consistency with NIH policies j. Document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other required fields on Case Report Forms.
• Assess study protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc. and generate quality assurance reports.
• Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
• Develops and implements systems for importing clinical data into the Biomedical Research Informatics Computing System (BRICS):
• Implement the existing method for transferring data from the NIH medical record system BTRIS into BRICS.
• Implement system for uploading outside clinical records, outside diagnostic tests, interviews, and
  questionnaires/surveys to research subject entries in BRICS. To achieve this, the role will work with Institutional Support systems listed below.
• Monitors subject's progress and reports adverse events.
• Retrieves/downloads automated clinical data reports from BRICS for study investigators upon request.
• Prepares reports – On a semiannual basis, prepares overview reports of clinical data management systems.
• Supports assembly, development and review of new research projects.
• Works with Data Science and Sharing Team to deposit clinical data into repositories upon publication of research findings.
• Updates clinical data management systems standard operating procedures (SOPs) as needed in the TIU Handbook.
• Supports the creation and management of clinical websites and web-based tools.
• Supervision of biospecimen pick-up and transport – Biospecimens collected at the NIH will be transported from the site of the clinical encounter to the NINDS BCR. The CRC will establish SOPs for biospecimen transport and supervise post-bac IRTAs, who will be responsible for physically transporting the biospecimen.
• Organizes and performs clinical research, utilizing internet and other available clinical resources.
• Establishes biospecimen data capture (biospecimen manifests) and data entry SOPs – Assists in the design and implementation of biospecimen manifest templates
• Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.
• Develops template for biospecimens received from within and outside of NIH.
• Supports clinical staff develop, implement and maintain clinical research data files and materials.
• Periodically updates templates to ensure consistency with BRICS platform.
• Ensures that biospecimen management SOPs are consistent with CLIA requirements.
• Prepares reports – On a semiannual basis, prepare reports that provide an overview of biospecimen program.
• Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.

1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked

Minimum Education

Bachelor

Additional Qualifications:

Field of Study

• Microbiology
• Molecular Biology

Software

• Biomedical Research Informatics Computing System
• Biomedical Translational Research Informatics
• Lab Archives

Skills

• Ordering, tracking, and managing IP and trial materials
• Implementation of clinical trial site action plans
• Coordinating project meetings

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

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