Clinical Research Assistant - Nih

TASKS

(1) Provide clinical research coordination through the National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trials Unit (CTU) for studies conducted in the Intramural Research Program

(2) Participate in coordination and management of daily study activities and ensure that study activities follow established protocols, Standard Operating Procedures (SOP), and utilize approved forms, templates and practices.

(3) Assist with preparing and submitting for review accurate study data collection forms and source documents related to research procedures

(4) 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 required fields.

(5) Enter data into research databases, systems and applications for ongoing studies

(6) Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.

(7) Assist researchers with study testing, collecting research samples, observations data entry and other duties associated with study sessions

(8) Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.

(9) Participate in developing study recruitment materials with input of investigators and IRB approval as well as assisting with outreach activities, as appropriate, to meet research recruitment and enrollment goals

(10) Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests.

(11) 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.

(12) Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices.

(13) Document, collect, record, and retain research related participant encounters including in person, phone, or electronic in the research records e.g. source documents, case report forms

(14) Assist with patient education and communications, study website updates, informed consent process, maintaining regulatory documentation, and ensuring continuity of care to patients enrolled on assigned protocols

(15) Adheres to applicable regulations, policies, and procedures related to clinical research including biospecimen handling shipments, study monitoring visits, and FDA audits

REQUIREMENTS

(1) Bachelor’s degree in Biology, Neuroscience, Public Health, Psychology, Sociology, or related scientific or health-related discipline with a minimum of 1-2 years of relevant research experience

(2) Experience/exposure to clinical research and clinical trials, study protocols, data collection, entry, and monitoring, and use of electronic medical records

(3) Experience/exposure to subject recruitment, scheduling visits/appointments, tracking supplies, and working with research study staff

Please Note: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.