Join the HJF Team!
The Henry M. Jackson Foundation is seeking a Research Assistant for the Epidemiology & Threat Assessment Department within the Military HIV Research Program (MHRP) located at Fort Bragg in North Carolina. HJF provides scientific, technical and programmatic support services to MHRP.
- Responsible for day-to-day operational issues related to the cohort study. Must be familiar with principles of Good Clinical Practice (GCP) in relation to clinical research, including informed consent, study objectives, data collection and reporting, and statistics.
- Determine whether or not volunteers meet all inclusion criteria. Educate study participants about the study, including potential risk and benefits; enroll and obtain consent from study participants, and maintain high-quality clinical records and documentation per GCP standards. Make public presentations as necessary for participant recruitment.
- Recruit and screen study participants. Maintain referral, screening, enrollment, and follow-up logs for the study. Work collaboratively with medical providers to determine what additional information, specimens, tests, or procedures are required to meet standards of medical care, and which are protocol specific and needed for patient enrollment (following consent).
- Implement study once approvals have been obtained. Identify issues with research design or analysis methodology once protocol implementation has started and monitors for methods to improve enrollment and follow-up. Submit protocol revisions as required to appropriate IRBs. Submit annual progress reports to MHRP, WRAIR as required.
- Ensure required lab tests are performed and all test results are recorded appropriately in medical records and in study documents per GCP standards. Ensure specimens are collected, processed and stored according to protocol requirements and GCP standards. Responsible for obtaining specimens required for enrollment and follow-up. Ensure all results are followed up accurately.
- Organize and maintain all research materials and binders at the highest standards, per GCP guidelines. Actively participate in IRB meetings relating to the research study. Maintain proficiency through training and other requirements as they relate to clinical research.
- Collect, organize, disseminate, and maintain appropriate files of current data and maintain status reports on all patients. Maintain quality assurance and recordkeeping procedures and manage appropriate participant records in accordance with applicable regulations, policies, and standards.
- Maintain documentation of ALL correspondence related to the clinical study to include, but not limited to:
- Protocol and regulatory binder
- Informed Consents
- Continuations of the study (based on annual or periodic reviews)
- Notices or advertisements for study recruitment
- Notification from the responsible IRB's
- ALL cohort study related documents
- ALL study participant files/folders
- Responsible for all data and source documentation. Provide clear, comprehensive documentation of study visits while adhering to specific protocol requirements, as well as ICH/GCP guidelines.
- Manage data entry assuring a high level of accuracy within the database. Supervise data entry by study participants.Organize data for analysis.
- Securely maintain the Confidential Patient Identification List. NOTE: This is a confidential list of the names of all patients with their study assigned identification numbers. It is maintained only at the site, and allows the investigator or institution to quickly identify study patients per protocol or in case of emergencies.
- Prepare and assist site with Protocol Reviews and Monitoring visits.
- Attend all study-specific meetings as well as instructional meetings, seminars, etc., as required for effective study execution.
- Communicate effectively and in a timely manner with investigators, IRBs, physicians, and other providers, as needed, regarding volunteers involved in the research study.
- Participate in the preparation of data for presentation at scientific meetings, and for publication in scientific journals.
- Provide assistance, consultation, assessment and monitoring of patients participating in or being evaluated for enrollment in project studies for actual and/or potential health problems.
- Participate in professional activities including association meetings, seminars, workshops, symposia, and review of current professional literature.
- Perform other related duties as assigned or requested by study site personnel.
Required Knowledge, Skills, and Abilities: Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications; Ability to use measurable and verifiable information for making decisions or judgments; Skill in statistical interpretation and data analysis using statistical software and/or spreadsheets and database software applications; Excellent organizational and project management skills.
Minimum Education/Training Requirements: Bachelors degree in Social Science such as Sociology, Psychology or related field.
Minimum Experience: 4-6 years of clinical research experience.
Physical Capabilities: long periods of standing and sitting
Work Environment: Office environment
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.