Alzheimer's Clinical Trials Consortium

Clinical Research Regulatory Coordinator

by

Function/Duties of Position

Layton Center clinical trials team Clinical Research Regulatory Coordinators (TI Senior Clinical Research Assistants) are highly organized and are responsible for duties related to supporting human subject research trials, including various regulatory needs.  Regulatory Coordinators must effectively and professionally communicate (verbally including by phone and video call as well as in writing) within the Layton Center clinical trials team, with other departments at OHSU including the IRB, and with study sponsors and contract research organizations (CROs). Regulatory Coordination
  • Continuing Reviews – Preparation and IRB submission of annual continuing reviews in collaboration with the Layton Center clinical trials team
  • Modifications – Preparation and IRB submission of updates to protocols, consent forms, etc. in collaboration with study sponsors and CROs
  • Reportable New Information (RNI) Reports – Preparation and IRB submission of RNI reports
  • Staff Changes – IRB submission of staff changes
  • Site Feasibility Questionnaires & Communication – Management of sponsor inquiries for potential trials including completion of site feasibility questionnaires
  • Study start-up activities, including initial submissions to OHSU IRB and industry sponsor IRBs; administration management in the OHSU clinical trials management system (eCRIS).
  • Assisting with study close-out activities
  • Routine correspondence with the OHSU IRB and industry sponsor IRBs related to required submissions, protocol modifications, and continuing reviews.
  • Regulatory document and binder maintenance in compliance with Good Clinical Practice (GCP) standards.
  • Preparation and maintenance of personnel sheets, delegation logs, and FDA Form 1572
  • Assistance with preparation for and coordination of monitoring visits.
  • Ensuring compliance with all protocol and regulatory requirements.
  • Attending, actively participating in, and providing updates at recurring Layton Center clinical trials team meetings.
  • Assisting leadership with ensuring consistent project management, complex logistics, quality assurance, and participant safety.
Clinical Research Assistant, Student Worker, and Volunteer Training and Supervision
  • Assistance with onboarding and training of clinical research assistants (CRAs), student workers, other staff, and volunteers – specifically related to duties involving regulatory work.
Maintenance of Research, Ethics, Compliance, and Safety Training
  • Ensuring that required Collaborative Institutional Training Initiative (CITI) program trainings are complete, up to date, and renewed in a timely manner.

Required Qualifications

  • Bachelor’s degree in relevant field AND 1 year of relevant experience OR Associate’s degree AND 3 years of relevant experience OR 4 years of relevant experience OR Equivalent combination of training and experience
  • Relevant experience must include regulatory activity experience
  • Working knowledge of scientific methods and human subjects research
  • Intermediate or advanced knowledge of Word, Excel, Outlook, and other MS Office programs
  • Demonstration of high level of attention to detail; self-starter; ability to prioritize work demands and manage time appropriately
  • Demonstrated high level of organization and ability to efficiently manage multiple tasks
  • Able to perform the essential functions of the position with or without accommodation
  • Must possess excellent written and verbal communication skills; be able to multi-task and enjoy working in a team

Preferred Qualifications

  • Therapeutic intervention clinical trial experience strongly preferred
  • SOCRA, CCRP or ACRP certification preferred

Senior Clinical Research RN or Clinical Research RN

by

Function/Duties of Position

This position is under the supervision of Dr. Aimee Pierce who serves as the clinic director, research clinical core lead, and clinical trials director at the Layton Aging & Alzheimer’s Disease Center. The Research Nurse is responsible for conducting cognitive neurology research study visits including recruitment and screening of volunteers, conduct of study visits, data entry; ensuring integrity and quality of protocol procedures and resultant data, maintaining regulatory compliance and documentation, managing investigational drugs and supplies. This position will also assist with providing backup for clinic duties: providing and assuring the highest standards of dementia care for patients enrolled in multiple clinical research protocols and/or the Memory Clinic; coordinating with clinic team members to ensure coverage and smooth, implementing nursing interventions and follow-up care; assisting providers and family in symptom management and in identifying community resources; maintaining comprehensive Epic/MyChart documentation.

Required Qualifications

Clinical Research RN:
  • BSN AND 3 years clinical experience preferably in a research setting AND BLS required (from American Heart Association)
Senior Clinical Research RN:
  • BSN AND 5 years clinical experience preferably in a research setting AND BLS required (from American Heart Association)
Job Related Knowledge, Skills and Abilities (Competencies):
  • Current unencumbered Oregon RN license
  • Strong interpersonal skills
  • Commitment to working in a team environment
  • Excellent written and verbal skills
  • Highly organized and able to work independently
  • Ability to prioritize multiple tasks at one time
  • Ability to work independently and as part of a team while being collaborative in resolving problems
  • Must be proficient with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint)
  • Must have demonstrated excellent customer service skills both on the phone and in person
  • Must possess energy and drive to coordinate multiple projects simultaneously
  • Ability to use tact and diplomacy to maintain effective working relationships

Preferred Qualifications

  • Experience and fluency with OHSU electronic records system (EPIC)
  • Research Certification (SoCra, ACRP)

Clinical Research Coordinator II

by

Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.

Clinical Research Manager

by

Stanford University is seeking a Clinical Research Manager to provide leadership and oversight of one large or multiple small clinical research projects. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight.

Neuroscience Faculty – DEIB Lead

by

THE MAYO CLINIC ALZHEIMER DISEASE RESEARCH CENTER invites applicants for an open-rank position in Neurosciences focused on Diversity, Equity, Inclusion & Belonging (DEIB) Science. The DEIB Lead will partner with the Mayo Clinic Alzheimer Disease Research Center (ADRC) Leadership Team to support the aims of the Center and initiatives to achieve short and long-term goals. Applicants should demonstrate broad knowledge of and commitment to research specific to DEIB science. The ideal candidate will maintain a strong research portfolio in areas including, but not limited to cognitive aging and dementia research among older adults, and brain health. Commensurate evidence of productivity is expected, including but not limited to peer-reviewed publications, grants, partnering with community stakeholders, establishing new research cohorts, or developing a focused curriculum. Potential candidates with experience in mixed-methods and community-based participatory research are encouraged to apply. This position will be based on the Mayo Clinic campus in Jacksonville, Florida. THE MAYO CLINIC ALZHEIMER DISEASE RESEARCH CENTER is internationally recognized and respected for academic excellence in the diagnosis, treatment, and investigation of age-related neurodegenerative diseases. The Mayo Clinic ADRC strives to promote the highest quality team-based research in neurodegenerative diseases and to translate this knowledge to improve population health. Faculty within the Mayo Clinic ADRC have expertise in behavioral neurology, neuropsychology, neurogenetics, neuropathology, disease modeling, immunity, and experimental therapeutics. ADRC faculty benefit from consistent extramural funding via the National Institutes of Health (NIA and NINDS), Florida State government, national and regional foundations, industry, and philanthropic partners. Collectively, these funding sources support community-based research that spans the spectrum of age-related neurodegenerative diseases, including Alzheimer disease, Lewy body disease, frontotemporal lobar degeneration, and vascular cognitive impairment. The research mission of the ADRC is supported through close collaboration with the Departments of Neuroscience, Neurology, and Neurosurgery.

Academic Faculty – Alzheimer’s Disease and related disorders

by

We seek applicants with an MD, PhD or equivalent degree and an established record of publications and extramural funding in Alzheimer’s disease and related disorders for tenure-track faculty positions at all ranks (Assistant, Associate or Full Professor). Investigators with research programs in any of the following areas are especially sought: 1) genomics/multi-omics; 2) population-based or health systems/EHR research focused on early detection and risk reduction; 3) data science; 4) health disparities; 5) clinical trials including pragmatic trials; and 6) biomarker discovery. Wake Forest University School of Medicine has designated Alzheimer’s disease as one of six prioritized research focus areas, which also include Aging, Neurosciences, Diabetes/Obesity, and Cardiovascular Disease. Wake Forest University School of Medicine is home to several highly collaborative NIH-funded Centers including an Alzheimer’s Disease Research Center, Pepper Older Adult Independence Center, Clinical and Translational Science Institute, and a Diabetes Research Center.