111328 - Clinical Trials Analyst
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#111328 Clinical Trials AnalystFiling Deadline: Mon 11/1/2021
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The Department of Pediatrics is one of the largest departments within The School of Medicine with approximately 164 Faculty, 72 post-doctoral fellows along with over 300 support staff (not including hospital staff). In addition, the Department of 110 clinical residents and fellows are 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 has undergone significant growth in recent years with a consolidated budget of approximately $138 million including sponsored projects expenditures of approximately $65 million and clinical revenue of over $73 million. This expansion of the Department’s research and clinical portfolio is expected to continue in the next few years.
The Department’s 17 divisions include Academic General Pediatrics, Child Development& Community Health; Allergy, Immunology and Rheumatology; Cardiology; Dysmorphology/Teratology; Emergency Medicine; Endocrinology; Gastroenterology; Genetics; Genome Information Sciences; Hematology/Oncology; Hospital Medicine; Infectious Diseases; Neonatology; Nephrology; Pharmacology & Drug Discovery; Rehabilitation Medicine; and Respiratory Medicine.
The Department’s Center for Better Beginnings consists of 85+ staff in Dysmorphology/Teratology and is involved in four major areas: 1) providing clinical services to patients with birth defects and developmental disabilities; 2) providing public health services in counseling patients, providers and education to the public about prenatal exposures and exposures during breastfeeding and their impact on child development and health; 3) a teaching program that includes undergraduate students, graduate students in epidemiology, medical students, and post-doctoral students, pediatrics, epidemiology, health behavior, global health, pharmacy, and other specialties; and 4) conducting clinical research to better understand the causes, prevention and treatment of birth defects and developmental disabilities. Research programs and projects within the Center involve federal, state and industry sponsored grants and contracts, which require complex interrelated infrastructure and shared resources both within the Center and with collaborators and subcontractors outside the Center.
Under direction of the Pregnancy Studies Research Manager the incumbent will draft proposals, protocols and amendments to protocols MotherToBaby / OTIS Pregnancy Studies research portfolio for the Division of Dysmorphology and Teratology.
Prepares annual reports, statistical analysis plans, and other sponsor study management guides, as well as monthly sponsor marketing reports. Monitors Institutional Review Board (IRB) activity submissions. Collaborate with Division Data Manager and Data Coordinator to organize Trial Master File (TMF) for all sponsors, including working with the IRB specialist and Marketing team to ensure IRB approval documents, and marketing materials are organized within the TMF. Perform document control, including formatting of all study documents. Manage study document folders and files. Participate in study audits.
Six (6) years of related experience, education/training, OR a Bachelor’s degree in related area plus two (2) years of related experience/training.
Thorough knowledge of relevant Federal and State regulations, and policies.
Strong ability to solve problems, issues; listen, interpret and confirm understanding of others' communications; and be objective.
Excellent customer service skills, pleasant, helpful and patient.
Effective, efficient and tactful oral and written communication skills. Ability to communicate effectively with staff, sponsors, and other collaborators in person and over the phone. Ability to problem solve and resolve conflict. Experience interacting positively, constructively, and effectively with staff, sponsors, and and other collaborators.
Ability to work in a team oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction.
Proficiency with computers, including the ability to operate personal computer software with sophisticated retrieval, storage, and merging capabilities. Knowledge of PC and MAC software applications including Word, Excel, and PowerPoint. Word processing and E-mail skills to produce reports, profiles, correspondence, graphs, and spreadsheets to generate and track required data.
Understanding of research activities and guidelines related to protocol writing, consent, ethical conduct and protection of human subjects. Ability to maintain patient confidentiality and communicate with professionalism, sensitivity and discretion.
Proven experience in drafting research protocols and procedure manuals. Excellent organizational skills. Strong attention to detail. Experience with formatting and editing documents, including references.
- Ability to collect, record, transcribe and synthesize research data. Solid writing skills to prepare and synthesize clear scientific reports, records, and procedures.
- Knowledge of and ability to communicate and ensure compliance of current UCSD policies and procedures. Knowledge of UCSD and other state and international research requirements.
- Employment is subject to a criminal background check.
- Occasional evenings and weekends may be required.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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