Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Department of Neurology. The position is located at 4488 Forest Park. This position is for the Medical School Campus.
The Senior (Sr.) Clinical Research Coordinator will serve as a coordinator for the Dominantly Inherited Alzheimer Network (DIAN), an international non- randomized natural history non-treatment study. The Sr. Coordinator will oversee site regulatory compliance, coordinate operational aspects of new site onboarding, help in the maintenance of existing sites, assist with study-wide quality assurance efforts, and support DIAN leadership and the DIAN Deputy Director.
PRIMARY DUTIES AND RESPONSIBILITIES:
Regulatory Compliance, Site Expansion and Site Management
The Sr. Coordinator will support the Clinical Core team with domestic and international site expansion efforts including all aspects of the start-up process, which may include assisting with translation of study documents, establishment of the master files, and training of team members per protocol requirements.
The Sr. Coordinator will maintain regular contact with those sites added as part of expansion efforts.� This includes regular phone calls, troubleshooting, and clinical-operational maintenance as needed.
Liaise with External Groups
Communicates with external vendors regarding bids, scope of work, and audit reports.
Interacts with external monitors and QC reviewers as necessary.
Works with vendors and external groups as necessary to fulfil duties in role as project manager and expediter.
Special data projects as requested.
Project Management, administrative support, and tracking as needed for cores.� Assists cores in meeting deadlines and study objectives by driving deadlines and project objectives.� May include, but is not limited to, scheduling meetings, agenda preparation, tracking progress, tracking budget and invoicing, etc.� May, at times, be a special project or one of limited duration.
Assist in the transition to ICH/GCP compliance for all cores, but specifically the Clinical Core.� Also aids in the study harmonization efforts undertaken by Obs and TU.
Assist with Management of Study Documents
Assists with the development and/or revision of the study protocol, consent forms, including visit packets, SOPs and procedure manuals to ensure data are captured uniformly across all sites.
Modifies and maintains version control of 130+ page visit packets in 5 languages administered at performance sites in 8 countries. Creates, in collaboration, forms as needed for the study.
Assists Deputy Director and relevant staff in organizing and executing grant related activities such as: Yearly progress reports, grant applications, forms and submissions as needed to maintain the grant with the NIH and supporting entities.
Assisting may include collection and review of reporting documents, follow-up with cores to complete needed information, project management as needed.
Perform other duties as assigned by members of the DIAN research team including support of clinical operations, and development of Clinical Core SOPs and budget development with new study initiatives may be required.
Bachelor’s degree plus a minimum of 3 years of clinical research experience with some level of lead or supervisory experience required; Master’s degree or a combination of work and education equaling 7 years may substitute for this requirement.
B.S. Nursing, BS/MS or BA in Health, Biology, Psychology, or other science.
3+ years of clinical research coordinator experience with some level of lead or supervisory and regulatory experience.
Greater than 5 years in research experience with multi-site coordination preferred.
A Master’s degree in Nursing or health related field is preferred.
CCRC, SOCRA , or ACRP certification preferred.
Prior Quality Assurance and/or study monitoring experience preferred.
Clinical research coordinator experience.
Current knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Office of Human Research Protection (OHRP), and other regulatory guidelines.
Ability to work closely and constructively with interdisciplinary teams and foster good working relationships with team and sites.
Commitment to support project, department and institution Standard Operating Procedures (SOPs), policies, and procedures.
Ability to communicate effectively (written and oral).
Ability to manage time, multi-task, and effectively prioritize projects to meet timelines.
Strong work ethic.
Highly self-motivated, goal oriented, and effective with minimal supervision.
Ability to use independent thought, judgment and creativity to formulate and implement effective solutions to complex problems.
Knowledge of and experience with MS Word and MS Excel or similar computer programs.
The hiring range for this position is $56,472 - $72,010 annually.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, 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.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
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