Clinical Research Manager - 133085

The Department of Pediatrics is one of the largest departments within the School of Medicine with approximately 250 Faculty, 127 postdoctoral fellows (both MDs and PhDs) along with over 320 support staff (not including hospital staff). In addition, the Department has 68 clinical residents distributed across the Divisions. The missions of research, education and patient care are intertwined, and are integral to the goals of the department.

The Department manages a university-affiliated children's health system with the physicians and leadership of the University of California, San Diego (UCSD), Rady Children's Hospital, and Rady Children's Specialists of San Diego, a Medical Practice Foundation, unifying pediatric patient care, research, education and community service programs.

The Schwimmer Lab is in the Division of Gastroenterology, Hepatology, and Nutrition in the Department of Pediatrics. Our lab conducts clinical and translational research studies on the subject of Nonalcoholic Fatty Liver Disease (NAFLD) with an emphasis on children and families. Our sponsored projects include NIH funded studies on the Natural History of NAFLD as well as foundation and industry sponsored studies of diagnostic and therapeutics for NAFLD.

The incumbent will be independently responsible for the development, execution and overall management of multiple study protocols for the Schwimmer Lab. Responsibilities will include contributing to the planning and development of research designs and methods; making important original contributions to intervention development and implementation; providing input and contributing original ideas of major methodological significance on research direction and data interpretation; providing leadership and direction to those conducting research within the Schwimmer Lab; reading and understanding scientific articles pertaining to related research and the use of technology in clinical trials and outcomes; directing the collection of clinical data and contributing to preparation of data for publication, presentations, and reporting. This includes coordinating with both internal and external organizations as needed for the oversight of ongoing research studies. Incumbent is responsible for protocol development, writing proposals, progress reports and manuscripts, creating informational and recruitment materials, assisting with the project budget and overseeing day to day patient activities, as well as acting as a liaison with other UCSD departments and community clinics / agencies for the purpose of implementation of studies.

Ensure the proper execution of administrative and regulatory activities including IRB requirements, grant progress reports, and University policies and procedures. Assure compliance with state and federal regulatory guidelines. Oversees the quality of the clinical research data, including databases and datasets. This position develops and maintains Standard Operating Procedures for ongoing research studies. Supervises research staff in the execution of the research protocols and research activities.

CT - Applies extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.

• Nine (9) years of related experience, education/training, OR a Bachelor's degree in related area plus five (5) years of related experience/training.

• 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. Demonstrated experience in research protocol activation, marketing, outreach, recruitment and maintaining a research study cohort. Experience interpreting clinical findings to assure compliance with the protocol and prompt reporting of adverse events and protocol deviations. Demonstrated experience in maintaining quality control in clinical trial protocols,including adherence to the protocol requirements and data management.

• Advanced ability to effectively lead one or more projects with competing to meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities. Demonstrated ability to plan, organize and implement clinical trials with complex logistics involving various sites and multiple tasks and priorities.

• In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems. Ability to read, understand, and learn study procedures from protocols

• Advanced communication skills; including verbal and written, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to communicate with participants, staff and physicians with professionalism, sensitivity and discretion. Skilled at negotiating with various personalities and developing internal and external network of contacts.

• 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.

• 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. Experience using clinical trials management software such as REDCap, Basecamp, and VELOS.

• 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. Demonstrated skill in establishing and maintaining effective relationships with staff of all levels, faculty and health care professionals.

• Advanced theoretical knowledge of a basic science such as Biology, Microbiology or a related field. Advanced theoretical background of research methods, protocol design, and implementation. Strong theoretical knowledge of scientific disciplines in addition to extensive experience in Pediatric Nonalcoholic Fatty Liver Disease clinical trials.

• Extensive experience and expertise in conducting clinical trials and the ability to train staff regarding Food and Drug Agency regulations and Good Clinical Practices. Understanding of research activities and guidelines related to consent, ethical conduct and protection of human subjects. Ability to maintain patient confidentiality.

• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Thorough Database Management skills, with computer software and internet proficiency.

• Experience performing anthropometrics, vital signs and using clinical laboratory equipment including pipettes, and centrifuges. Experience with blood processing and IATA certification to ship biological samples.

• Advanced skills in data analysis, presentation and publication. Extensive experience collecting, evaluating, and summarizing scientific data.

• Demonstrated ability to take patient history, evaluate patient problems and provide complete documentation in patient record.

• Demonstrated knowledge of and experience with cost accounting as applied to both University and Medical Center functions. Demonstrated knowledge of medical billing and collections guidelines and procedures.

• Bilingual, English/Spanish speaking.

• Job offer is contingent upon satisfactory clearance based on Background Check results.

• Occasional evenings and weekends may be required.

• Employment is subject to a criminal background check.