Assistant Clinical Research Coordinator - 138842

The Women's Pelvic Medicine (WPMC) research group includes 5 faculty, 3 rotating clinical fellows and rotating gynecology and urology residents. The core research team is comprised of a full time Research Compliance Analyst with a MPH and 2 years of clinical trials management experience who will be responsible for supervision and implementation of all active research protocols, two undergraduate level part time administrative support staff and a Clinical Research Coordination Assistant who will be responsible for working closely with the principle investigators, RCA and students in the implementation of several existing and new protocols developed over the coming years. The UCSD Women's Pelvic Medicine Research group is a standing member of several NIH sponsored research consortiums including PFDN; Pelvic Floor Disorders network and PLUS; Prevention of Lower Urinary Tract Symptoms. The group also participates in industry sponsored studies and smaller clinical trials Currently the group is participating in multiple active research protocols and maintaining records and compliance documents for multiple studies. The group anticipates continued grant support from federal and industry sources with new protocols under development and review.

1. The Burnett Lab conducts a variety of clinical trials (observational, interventional, and biospecimens-focused) focused on care of women at risk for pelvic floor disorders such as fecal/urinary incontinence and pelvic organ prolapse. The Pelvic Health After Birth Program (PHAB) is a research collaboration between three universities and medical institutions around the nation. UCSD PHAB/Burnett Lab are currently conducting research protocol activities on approximately 40 active patients.
2. The main research activities center around observational and interventional clinical trials on women at risk for pelvic floor disorders.
3. Additional PHAB protocols in startup phase will focus on biospecimen collection, processing and shipment to a biomed laboratory.
4. Other industry sponsored clinical trials include interventional studies of women undergoing phage treatment for recurrent urinary tract infection.

When necessary, our unit provides research support to other principal investigators within the Obstetrics, Gynecology & Reproductive Sciences Department time and resources permitting.

Reports directly to the Director of the Pelvic Health After Birth Program. Assist with coordination and management of clinical trials including supporting all aspects of protocol research protocol development/management, including screening for patient eligibility Under supervision of the Principal Investigator, the Assistant Clinical Research Coordinator is responsible for coordinating and managing clinical research studies within Burnett Lab/PHAB, including providing support for all aspects of protocol implementation and management. Responsibilities include screening for patient eligibility; participant recruitment and follow-up; coordinating and scheduling study visits; data collection and analysis; ensuring protocol compliance; monitoring and documentation of adverse events; laboratory and specimen collection, processing, and submission; and maintenance of accurate and complete clinical research files.

The incumbent will recruit and follow participants throughout pregnancy, labor and delivery, and the postpartum period in studies examining pelvic floor function and recovery. The role requires knowledge of vaginal delivery-related trauma and postpartum recovery, and the ability to obtain and respond to sensitive personal information in a professional and culturally appropriate manner.

The Assistant Clinical Research Coordinator assists with preparation and submission of Institutional Review Board (IRB) applications, renewals, amendments, and safety reports; supports study start-up activities; and assists with development and monitoring of study budgets and research-related financial documentation. The Assistant Clinical Research Coordinator is responsible for supporting implementation of protocol-driven exercise and movement-based interventions, including structured group sessions, and utilization of wearable or sensor-based technologies for research data collection. Prior experience with exercise-based clinical research, wearable or motion capture technologies, and maternal health-focused studies is preferred.

The incumbent will collaborate with multidisciplinary clinical and research teams, participate in regular research meetings, assist with dissemination of study materials to clinical partners, and perform other duties as assigned.

• Theoretical knowledge of biology, bioengineering, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.

• Experience performing clinical research duties in a clinical research environment.

• Must have current CITI certification for Human Subjects Research.

• Must maintain current Basic Life Support (BLS) certification.

• Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.

• Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.

• Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.

• Experience interpreting medical charts, experience in abstracting data from medical records.

• Experience with clinical trials participant or study subject recruitment.

• Experience maintaining files and keeping records.

• Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.

• Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills.

• Ability to work independently. Ability to maintain confidentiality.

• Experience completing clinical trials case report forms via hard copy and online.

• Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.

• Experience preparing and assisting with Institutional Review Board (IRB) submissions, renewals, and amendments in compliance with human subjects research regulations.

• Experience providing in-service training to various research personnel on protocols, processes, and procedures.

• Experience coordinating study startup activities.

• Ability to safely assist with physical assessments and structured movement or exercise sessions as required by study protocols.

• Experience with wearable or sensor-based technologies (e.g., Motion Tape) for research data collection, including application and fabrication and motion capture systems

• Demonstrated experience in OB/GYN research and knowledge of vaginal delivery-related trauma and pelvic floor recovery

• Experience managing and leading structured large group sessions.

• Personal Training Certification or comparable credential.

• Experience implementing protocol-driven exercise or movement-based interventions.

• Knowledge of x-rays, scans, and other procedures including perineometry and biofeedback.

• Employment is subject to a criminal background check and pre-employment physical.

• Must maintain current CITI certification for Human Subjects Research.

• Occasional evenings and weekends may be required to accommodate participant scheduling and study-related activities. Work hours may occasionally extend up to 7:00 PM based on study needs.

• Must have access to reliable transportation and be willing to travel to sites within San Diego County

• Must be willing to travel domestically on weekly basis to attend investigator meetings, trainings, or study-related activities.

• Must maintain current Basic Life Support (BLS) certification

• Ability to safely assist with physical assessments and structured movement or exercise sessions as required by study protocols.