Medical Operations and Medical Safety Associate
Posted 28 Oct 2020
University of California, San Diego
San Diego , California
Please apply using the link provided below under the requirements.
The primary role of the Medical Safety Core (MSC), which includes medical operations and medical safety, is to monitor participant safety, ensure data integrity, collaborate with the ADCS DSMB, and report to regulatory entities as necessary, for all ADCS clinical trials. This includes oversight of real-time adverse event, serious adverse event, and SUSAR coding and monitoring, as well as safety report production and distribution.
The medical operations and medical safety associate (MOMSA) of the MSC participates in the daily activities of all medical core operations, works closely with other medical operations staff, and with the faculty of the medical safety team, serves as a liaison between the clinical monitoring (CRAs) and medical monitoring teams and their related activities within the MSC for all ADCS clinical trials.
This position requires a high degree of independence and grants a high degree of autonomy. It also falls within a matrixed reporting structure, and reports to the MSC director and the ADCS Director, takes direction from others as needed, and can expect to work closely with the director of administration and business operations for HR matters, and business operations.
The majority of this position is devoted to medical operations activities such as managing and coding medical data of AEs and SAEs using coding software and dictionaries (e.g., Omnicom TrialMaster AutoEncoder, WhoDrug, MedDRA) and conducting statistical analyses of safety data with programs such as SPSS and R. A lesser amount of effort is allocated to medical monitoring, including review of participant eligibility based on inclusion and exclusion criteria as defined per protocol. The effort devoted to the medical monitoring portion of this position fluctuates depending on the demands, number, and complexity of ADCS clinical trials at any given time, while the medical operations portion of this position is less affected by these fluctuations. The MOMSA can expect a minimum percent effort dedicated to medical operations of ~80 percent, with the remaining percent effort adjusted based on medical monitoring needs as well as other ADCS activities, special or ad-hoc projects, as assigned.
In addition, the MOMSA will coordinate activities between the MSC and other ADCS functional groups in order to facilitate clinical trial activities, contributing to future projects for ADCS pipeline of clinical trials, and primary objectives of the ADCS; and in particular, will work closely with the director of clinical monitoring to serve as a bridge between CRAs and medical monitors (physicians) to increase communication and connect their highly integrated activities. The MOMSA will assist in educating ADCS teams, including CRAs and clinical operations staff, on protocol-specific medical operations and medical safety issues in order to standardize clinical monitoring functions and to ensure consistency, which is important when addressing site queries, especially those concerning inclusion and exclusion criteria.
The MOMSA will support preparation of medical safety data reports for clinical trials for submission to various entities, including funding agencies, industry sponsors, auditors, and various regulatory agencies as well as the ADCS Data and Safety Monitoring Board (DSMB)—including taking meeting minutes and disseminating them for review and approval. These reports can include descriptive and inferential statistics, as well as graphs, tables, and written summaries.
The MOMSA also functions independently in the development of ADCS research protocols, and may be called on to contribute to design, methods, and analysis plans for ongoing, new, and potential studies/clinical trials. The MOMSA may assist in grant and protocol writing as well as trial designs based on the needs of the ADCS and its potential collaborators. The MOMSA oversees and assists in the development and maintenance of all Standard Operating Procedures (SOPs) for MSC Operations and reviews SOPs that effect other functional groups as needed that involve/relate to the MSC.
The MOMSA will also function as a medical monitor for ADCS clinical trials, and while performing these duties, it is expected that the MOMSA will use good clinical judgment when fielding questions regarding participant eligibility per inclusion/exclusion criteria, especially those falling outside of the study protocol, such as potential protocol violations and deviations as they may effect the protocol. The medical monitoring portion of this position will vary depending on the number of ADCS clinical trials at any given time, as well as their complexity, and on average, would constitute up to 20 percent of this role.
Applies extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.
- Bachelor's degree in related area of neuroscience and/or equivalent experience/training.
- Five or more years of relevant clinical trials experience.
- Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements. Knowledge of Good Clinical Practices (GCP), FDA clinical trial regulations, AD clinical trials.
- Advanced ability to effectively lead one or more 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.
- As the ADCS is a cooperative study, the incumbent must be flexible and comfortable with building a knowledge base outside of their primary focus.
- In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems. Clinical trials timelines are constantly in flux due to the nature of enrolling participants. Candidate must be able to think strategically and "outside the box" to find solutions to roadblocks as well as foresee potential roadblocks before they become an issue.
- Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills.
- Clear and concise communicator. Must possess the skills to communicate complex ideas so that they are easily understood by a wide-range of audiences.
- Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members.
- Works 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.
- Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced 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 and CTMS.
- In depth ability to work collaboratively with other cross-functional teams.
- In depth ability to interface, collaborate and influence/persuade other members of an extended study team. 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.
- 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.
- Hands-on experience with medical coding, statistical data analysis and data management.
- Ability to present data to a scientific/regulatory body such as a Data Safety Monitoring Board, make recommendations for altering research and/or scientific protocol(s) based on data analyses, trends, etc..
- Hands-on experience with data visualization and presentation in the context of clinical research.
- Background in neurology or neurosciences is a must.
- Higher knowledge of medical and scientific terminology including diseases and symptoms and medication names for classification. Advanced knowledge of the Medical Dictionary for Regulatory Activities (MedDRA).
- Theoretical and applied knowledge of medicine, biology, neurology/neuroscience, and statistics.
- Advanced skills in data analysis, including statistical design, methodology, and statistical modeling. Statistical analyses of clinical trial data to produce reports is required. Hands-on experience with medical coding, statistical data analysis and data management. Hands-on experience with data visualization and presentation in the context of clinical research. Skill to analyze research data with SPSS and/or R to contribute to writing reports and other documents detailing ADCS clinical trials. Use tools in association with R such as RStudio, Tidyverse, dplyr and/or ggplot2. Creates medical safety reports and reports using MS Word, MS Power Point, and Adobe Acrobat to summarize medical data for the DSMB, trial sponsors, and ADCS faculty and staff.
- Knowledge of computerized database management systems and downloading/uploading data, EDC and CTMS in particular. Prior experience with Trial Master and Clinical Conductor preferred.
- Demonstrated experience directing, organizing, and prioritizing workload to meet required deadlines and department objectives. Must be flexible as percentage effort devoted to specific each task listed in job description may change as trial needs change.
- Excellent communication skills, both written and verbal. Skill in working with a diverse group of faculty, staff, and industrial collaborators.
- Demonstrated leadership and strong decision-making skills and ability to use independent judgment to quickly set priorities, solve problems and resolve conflict. Demonstrated ability to respond effectively to unexpected events and crises.
- Experience with protocol development, including original writing, development of tables/graphs, summation of background literature, editing of multiple draft versions, and review of galley proofs.
- Knowledge of FDA regulations regarding the good conduct of clinical trials.
- Skill in deciphering complex medical patient charts for extraction of Adverse Event, Serious Adverse Event, and SUSAR data.
- Skill in coding medical data for Adverse Events and Serious Adverse Events for FDA reporting utilizing specialized coding software (such as AUTOCODE).
- Knowledge of WhoDrug, MeDRA, and conmeds coding highly preferred.
- Skill and knowledge in a variety of disciplines including analyzing data for trends and/or preparation of grants, neurology/neurosciences, and AD clinical trials
- M.D. degree (foreign M.D. OK—U.S. license not required) and five (5) or more years of relevant clinical trials experience.
For full job posting and to apply, please visit this link: https://jobs.ucsd.edu/bulletin/job.aspx?jobnum_in=106360