Clinical Research Coordinator Jobs

Axle Informatics 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 highly ambitious, adaptable, structured, and detail-oriented Clinical Research Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.

Overall Position Summary And Objectives

The primary role for this Research Coordinator (RC) position is to provide clinical research coordination through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned.

Deliverables

• Contribute to interdisciplinary teams, participate in meetings, workgroup processes; provide substantive outcomes; complete assignments within established timeframes. - Daily
• Educate participants and families; perform individualized teaching; advocate and support participants' rights; identify learning needs for practice environment; explore and communicate research issues. - Ad-Hoc
• Collect participant data; obtain informed consent/assent; respond to and report variances in protocol implement; collect and record research information, perform research procedures as qualified and assigned. - Ad-Hoc
• Manage conflicts/issues in clinical research setting; assess participants and families; provide verbal responses to participants and families; respond to inquiries from the general public and health care professionals regarding clinical research protocols. - Ad-Hoc

Work Details

• Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
• Participate in developing and maintaining research protocol documentation and operations.
• Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
• Adheres to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research including biospecimen handling shipment.
• Provide continuity of care to patients enrolled on assigned protocols.
• Maintains the privacy and confidentiality of participant and research data; Protects participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
• Assist researchers to coordinate, facilitate and prepare site for monitoring visits and FDA audits.
• Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
• Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse
• Verify study participant information and collect data and results of testing.
• Review draft protocols, case report forms, and manuals of operations for clarity, and completeness.
• Participates in developing recruitment materials with input of investigators and IRB approval for referral sources outlining eligibility information.
• Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts.
• Supports clinical staff develop, implement and maintain clinical research data files and materials.
• Supports the creation and management of clinical websites and web-based tools.
• Assesses participants understanding of the information provided during the informed consent process
• Maintain content on the Clinical Studies websites (resources for staff and extramural investigators).
• Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests.
• Obtain or confirm informed consent and or assent completion prior to the beginning of any studies or therapies.
• Documents, collects, records, and retains all research related participant encounters including in person, phone, or
• Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices.
• Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.
• Serves as a communication liaison between interdisciplinary team and the research participant.
• Supports assembly, development and review of new research projects.
• Identifies and intervenes to address facilitators and barriers to effective informed consent discussions and decision making eg, literacy, capacity, language, distress, lack of time, therapeutic misconception.
• Assist researchers with the collection and analysis of research data and samples.
• Supports clinical staff develop, implement and maintain clinical research data files and materials.
• Notes trends in toxicities, participant information, and data collection points.
• Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
• Maintains the privacy and confidentiality of participant and research data; Protects participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
• Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.
• Assist preparing and submitting for review accurate source documents related to all research procedures. 2
• Collaborate with information technology (IT) staff to perform updates to a variety of websites.
• Set up, format and enter data into spreadsheets to analyze information and create reports.
• Manages conflicts issues that arise in clinical research setting, by utilizing strong communication and collaboration skills.
• Electronic in the research record eg source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents.
• Enter data into research databases, systems and applications for ongoing studies. 4
• Creates and updates protocol operating policies and procedures eg MOPs as needed.
• Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.
• Maintain a current clinical trial and clinical research study Good Clinical Practice GCP knowledge base, in order to serve as an expert resource to the client in a regularly changing field, and addresses identified knowledge and skill gaps related to role.
• Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.
• Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices. 1
• Performs and or coordinates outreach activities, as appropriate to meet research recruitment and enrollment goals.
• Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries.
• Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
• Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices.
• Electronic in the research record eg source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents.
• Assesses ongoing consent through discussions with participants and reinforcement of education
• Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures.
• Monitors subject's progress and reports adverse events.
• Contributes to discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, and data quality.
• Identifies and develops relationships with institutional or community-based resources or groups that can assist in achieving recruitment goals.
• Complies with processes and procedures required by different types of sponsors and contractual partners eg private industry, federal agency, and investigator.
• Documents, collects, records, and retains all research related participant encounters including in person, phone, or
• Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.
• Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
• Assist researchers in the design of participant Case Report Forms (CRFs).
• Creates and updates protocol operating policies and procedures eg MOPs as needed.
• Assist researchers develop, maintain and complete study data collection forms and source documents.
• Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.
• Provides a redacted copy of the informed consent form for regulatory submission at time of continuing review.
• Ensure Case Report Forms (CRFs) are complete and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields. 3
• Update and maintain logs and records of patient and family contacts.
• Anticipates and consistently meets reporting deadlines, collaborating with PIs and teams to note data trends and identify problems.
• Supports the development of forms and questionnaires.
• Collects research data and prepares information for inputs and analysis.
• Performs problems-solving and improves processes as needed to resolve complex and or unpredictable situations.
• Assist researchers with study testing, observations data entry and other duties associated with study sessions. 5
• Create mock ups and visualizations to illustrate to web developers how to execute web enhancements or new web requirements.

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

Minimum Education

Bachelor's

Additional Qualifications

Field of Study

• Communication Disorders Sciences and Services
• Cognitive Science and Biopsychology
• Miscellaneous Psychology
• General Medical and Health Services
• Pharmacy Pharmaceutical Sciences and Administration
• Miscellaneous Social Sciences
• Biology
• Miscellaneous Health Medical Professions
• Nutrition Sciences
• Interdisciplinary Social Sciences
• Multi-Disciplinary or General Science
• Community and Public Health
• Psychology
• Genetics
• Miscellaneous Biology
• Health and Medical Preparatory Programs
• General Social Sciences
• Social Work
• Sociology
• Treatment Therapy Professions
• Neuroscience
• Social Psychology
• Clinical Psychology
• Chemistry
• Nursing

Software

• General data acquisition programs
• Microsoft Office Suite

Skills

• Phase I or II experience
• Remote site monitoring
• Ordering, tracking, and managing IP and trial materials
• Research
• Regulatory compliance
• Protocol review revision
• Data Monitoring
• Training clinical trial site staff
• Implementation of clinical trial site action plans
• Data Integrity
• Protocol writing
• SOPs
• Screening
• Clinical Research
• Previous clinical trial work
• Patient care
• Protocol development
• Overseeing and documenting IP dispensing, inventory and reconciliation
• Patient confidentiality
• Recruitment
• Closing clinical trial sites down on completion of clinical trial
• Electronic medical records
• Clinical Trials
• ICH/GCP
• Scheduling
• Coordinating project meetings

Benefits

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

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 [email protected]

DisclaimerThe above description is meant to illustrate the general nature of work and level of effort being performed by individual’s 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.