This position will work a hybrid schedule which includes a combination of working both onsite in La Jolla and remote, but is subject to change.

DESCRIPTION

The Alzheimer's Disease Cooperative Study (ADCS) was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS is a multi-center clinical trials consortium that provides an operational framework for large-scale Alzheimer's disease research projects. The ADCS consists of 7 cores, 22 committees, 39 research sites that are members of the consortium/Steering Committee, and an additional 40 or more research sites located across the U.S. and Canada that participate in one or more trials coordinated by the ADCS. Annual funding for the ADCS ranges from $15-$25M. The ADCS provides expertise in developing Alzheimer's disease-related protocols and is the coordinating center for multiple clinical trials of varying sizes and complexity under subcontracts funded by NIH and clinical trial agreements with industry partners.

The Medical Operations Specialist of the ADCS Medical Safety Core (MSC) assists with the daily activities of all medical core operations, works closely with other medical operations faculty and staff, and assists with the pharmacovigilance activities of the MSC, including medical coding using MedDRA and coding concomitant medication using WHOdrug, for all ADCS clinical trials. The MO Specialist will help coordinate activities between the MSC and other ADCS functional groups to facilitate clinical trial activities, projects, and primary objectives of the ADCS. The MO Specialist will assist with the development and maintenance of all Standard Operating Procedures (SOPs) for MSC Operations and will create, maintain, and execute processes for the triage and organization of MSC communications and documents for each respective electronic Trial Master Files (eTMFs). In addition, the MO Specialist will support other MSC team members with our Data Safety Monitoring Board (DSMB) activities, ad hoc reports, publication/literature reviews, and other projects as directed.

The primary role of the MSC is to monitor participant safety and help ensure data integrity for all ADCS clinical trials. Operational roles include oversight of adverse events and serious adverse events, data coding and monitoring, as well as safety report production and distribution. The MO Specialist also assists with the preparation and distribution of statistical medical safety data reports for clinical trials for submission to the ADCS DSMB. In addition, the MO Specialist will track and document electronic alerts related to participant safety data (such as abnormal labs), prepare and archive agendas and minutes of MSC meetings, and will assist with the organization of communications involving ADCS Medical Monitors.

MINIMUM QUALIFICATIONS

• Seven (7) years of related experience or a BA/BS in biology, psychological science, ethics, medicine, or related fields plus a minimum of three (3) years of related experience. Theoretical and applied knowledge of medicine, biology, neurology, and statistics.

• Demonstrated self-discipline and sound, independent judgment completing complex assignments. Clinical trials timelines are constantly in flux due to the nature of enrolling participants. Candidate must be able to apply strong decision making, independent judgment, and critical thinking skills strategically and creatively/"outside the box" to find solutions to roadblocks as well as foresee potential roadblocks before they become an issue.

• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents. Intermediate to advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Knowledge of regulatory requirements. Knowledge of Good Clinical Practices (GCP), FDA clinical trial regulations, Health Insurance Portability and Accountability Act (HIPAA), and neuroscience-based clinical trials.

• Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology. Knowledge of medical and scientific terminology including diseases and symptoms and medication names for classification.

• Demonstrated proficiency in public speaking, and writing. Advanced communication and interpersonal skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills problem-solving, and collaboration with other team members. Must possess the skills to communicate complex ideas concisely so that they are easily understood by a wide-range of audiences. Must work well with others to achieve common goals. In particular, must be able to bridge both internal and external groups to achieve clear lines of communication.

• Demonstrated ability to effectively lead one or more competing projects to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities. Because clinical trial start-up and close-out activities are very demanding, must be adept at re-prioritizing projects and deadlines.

• Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems. Must be open to training on new systems, including EDC,CTMS, and MedSafety-related systems.

• Candidate must be adept at working with a wide-range of specialties, skill-levels, and authority (faculty, staff, and students).

• Experience in the development, implementation, and maintenance of Standard Operating Procedures (SOPs) appropriate for clinical trials research.

• Knowledge of good conduct of clinical trials and clinical trial design, FDA safety reporting requirements and practices, and the Health Insurance Portability and Accountability Act (HIPAA).

• Skills in researching, acquiring, and learning to use new or specialized computer programs/software for addressing queries and for analysis. Competence in Microsoft Office Suite.

• Ability to present scientific research to a scientific/regulatory body such as a Data Safety Monitoring Board, make recommendations for altering research and/or scientific protocol(s) based on findings or concerns of safety oversight agencies.

• Knowledge of computerized database management systems and downloading/uploading data.

• Demonstrated experience directing, organizing, and prioritizing workload to meet required deadlines and department objectives.

• Demonstrated ability to respond effectively to unexpected events and crises.

• Knowledge of FDA regulations regarding the good conduct of clinical trials.

PREFERRED QUALIFICATIONS

• Master's degree in a related field.

• Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.

• Skill and knowledge in a variety of disciplines including data analysis, ethics, and epidemiology.

• Knowledge of WHOdrug, MedDRA, and conmeds coding highly preferred.

• Skill in coding medical data for Adverse Events and Serious Adverse Events for FDA reporting utilizing specialized coding software (such as AUTOCODE).

• Skill in deciphering complex medical patient charts for extraction of Adverse Event, Serious Adverse Event, and SUSAR data.

• Clinical trials experience preferred.

SPECIAL CONDITIONS

• Occasional travel may be required.

• Must be willing to work outside of normal business hours as necessary.