- Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research.
Knowledge and understanding of health equity, social determinants of health as well as cultural challenges to recruitment and retention in the community; has public health and health communication experience.
Knowledge and understanding of Federal regulations and guidelines governing the protection of human subjects (e.g., HIPAA, FDA, OHRP, GCP/ICH).
Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
Knowledge and understanding of implementation, and coordination of community outreach initiatives and general grant-funded operations
Understanding and capability to accurately and compliantly perform the processes and activities required for community outreach protocols. Ability to identify and troubleshoot problems.
Conducts detailed in-person and telephone-based screening of potential research participants and their study partners, including entry of information into REDCap database.
Accurately and compliantly prepares and maintains documents required to be maintained internally and available for leadership and regulatory authorities on outreach, recruitment, and retention activities
Identifies and procures equipment and supplies needed to fulfill project requirements and activities.
Supports the creation, coordination, and implementation of community outreach, engagement, and public relations activities to recruit a diverse group of middle-aged and older adults for participation in Alzheimer's disease research with a focus on persons from underrepresented racial groups.
Supports Community Advisory Council activities, including scheduling meetings, preparing the agenda, and taking and distributing meeting minutes.
Provides support in data entry, developing, extracting reports using the Center's REDCap participant recruitment database
Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
With direction, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies
Serves as an ambassador for community awareness of Vanderbilt Memory and Alzheimer's Center and an advocate for human subjects by helping to establish and maintain communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations through ongoing monitoring of community and participant feedback.
Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in the Center's Participant Registry database and referred for clinical/translational trials and study opportunities.
Supports the preparation and delivery of informative, scientifically-sound presentations and other promotional materials to community audiences.
Helps to establish and maintain interdepartmental collaboration, relationships with community medical facilities, community agencies, churches, and other social programs in the area.
Engages in open communication with community members, community partners, and participants providing them with contact information and being available to answer, address or refer their calls.
Interacts with participants during their study visits at the medical center.
Supports the development of creative and innovative community engagement activities, including in-person presentations and events, as well as digital engagement opportunities through social media.
Trains others in completing enrollment calls for the Center's REDCap participant recruitment database.
Utilizes or acquires knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development.
Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
Engages in a minimum of 10 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification.
Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and Sponsor
Participates in research related programs, such as the Clinical/Translational Research Staff Council and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel.
Furthers knowledge by completing more advanced job-related educations (such as Research Support Services Boot Camp Follow-up). Actively seeks new learning opportunities, seeing learning as a part of work. Develops and achieves personal and professional goals.