This position offers a hybrid schedule - flexibility working on-site and remote.
The Clinical Research Coordinator II is a member of a multi-disciplinary research team and works closely with the DIAN Expanded Registry senior coordinator. This position involves screening and identification of potential research participants, particularly those at risk for early onset dominantly inherited Alzheimerâ™s disease (AD caused by a genetic mutation). The Clinical Research Coordinator II interacts with families/primary caregivers and patients with mild dementia and healthy volunteers, as well as medical professionals related to their care. This position is responsible for organizing communications with these rare families including a quarterly newsletters, semi-annual informational webinars, and large meetings and conferences attended by families, AD researchers, pharma, regulators and philanthropic organizations. This position also supports recruitment for multiple international trials for the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) conducted in accordance with ICH/GCP and local regional requirements from protocol concept through clinical study report. This position contributes to the development of study protocols and procedures manuals, and will be responsible for annual Institutional Review Board research plan development, submissions and amendments.
The DIAN-TU is the coordinating center for major drug trials for the prevention of Alzheimerâ™s disease. The DIAN-TU, including the DIAN-TU Trials, is funded through a partnership between Washington University, the Alzheimerâ™s Association, pharmaceutical companies, the National Institute on Aging, GHR Foundation, and other philanthropic organizations. Washington University (DIAN-TU) will serve as the regulatory sponsor and FDA IND holder for the trial(s).
Primary Duties and Responsibilities
Serves as the initial point of contact for new registrants into the DIAN Expanded Registry (EXR).
Contacts and screens new family registrants and other referred, potential participants to identify those at risk for dominantly inherited Alzheimer's disease (DIAD); determines interest for study participation and generates family pedigrees using Progeny software (or comparable).
Makes and/or participates in making determinations of eligibility based on diagnostic criteria and/or observations/analysis in participant interviews.
Explains study options and refers eligible participants to study performance sites; tracks referred participant enrollment into the DIAN and DIAN-TU studies.
Assists in arranging for genetic counseling for new DIAN-TU trial subjects.
Manages the Exploratory Genetic Counseling and Testing (GCT) program, which provides genetic counseling and testing to identify individuals and families at risk for dominantly inherited Alzheimer's disease.
Participates on the DIAN Clinical/Genetics committee and assists the committee chairperson in scheduling meetings, preparing agendas, running meetings, taking minutes and helping the committee follow through on action items; responsible for archiving materials generated by and relevant to the Clinical/Genetics committee.
Responds to researchers/professional registrants and maintains contact with them.
Organizes family conferences for DIAD families (international and domestic).
Coordinates meetings of the conference planning committee, which includes family members, funding agencies, researchers, DIAN EXR leadership and staff, and DIAN Observational study staff.
Creates planning meeting agenda, leads meetings and provides minutes to planning committee.
Plans and manages conference logistics, budget, travel for conference attendees and speakers, conference presentations and materials.
Assists in preparation of final conference report.
Collaborates with DIAN EXR senior coordinator on outreach and expansion efforts of DIAN EXR.
Prepares DIAN EXR quarterly newsletter for participants.
Assists in preparation and execution of semi-annual and ad hoc DIAD Family webinars.
Collaborates in re-design of DIAN website; manages and executes periodic updates to the DIAN website.
Prepares written and/or oral presentations or reports and analyses.
Engages in creative approaches in recruitment and retention of DIAN EXR participants.
Implements and manages all phases of DIAN EXR protocol.
Ensures compliance with protocol guidelines and maintains record-keeping systems (REDCap, JIRA, Confluence, others).
Prepares submissions to the Institutional Review Board (IRB); resolves IRB/protocol management issues and recommends correction action as appropriate.
Coordinates the preparation of Standard Operating Procedures (SOPs) and other manuals specific to the DIAN EXR.
Facilitates communication with the DIAN Observational study and DIAN-TU Trial site investigators and coordinators.
Assists with manuscript and grant preparation jointly with the research group.
Performs other duties incidental to the work described herein.
Graduate of an accredited nursing program.
2+ years of related research in an academic research setting or clinical trial conduct experience.
Experience with genetic mutation research.
Clinical research certification.
Experience with IRB submissions.
Experience with REDCap and Canva.
Expert clinical skills, critical thinking, therapeutic communication, selfâ‘starter, able to function independently, strong writing abilities, empathetic. Â
Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of database management, spreadsheet development and other computer functions desirable.
Bachelorâ™s degree plus a minimum of two years of clinical research experience; a combination of relevant work and education equaling six years may substitute for this requirement.
$50,600.00 - $75,800.00 / AnnuallyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Washington University in St. Louis is committed to providing a comprehensive and competitive benefits package to our employees. Benefits eligibility is subject to employment status, full-time equivalent (FTE) workload, and weekly standard hours. Please visit our website at https://hr.wustl.edu/benefits/ to view a summary of benefits.
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the Universityâ™s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.
Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment â“ fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
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