Clinical Research Supervisor 1 - 136564

The UCSD Department of Obstetrics, Gynecology and Reproductive Sciences is composed of 65 faculty 14 clinical fellows, 4 Assistant Project Scientists/Postdoctoral Fellows. The department is composed of 7 divisions: Obstetrics and Gynecology, Maternal-Fetal Medicine, Gynecologic Oncology, Reproductive Endocrinology and Infertility, Hospitalist, Family Planning and Urogynecologic and Reconstructive Surgery. The department is currently ranked 5th in the nation in NIH funding among ObGyn departments.

Supervises staff involved in routine research study coordination. Receives predetermined work assignments that are subject to a moderate level of control and review. Oversees staff in execution of assignments; trains and mentors staff to improve quality and quantity of work.

Reporting directly to the Principal Investigator, is responsible for planning, coordinating, and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, enrollment and maintenance of subjects, data collection and analysis, biospecimen collection and processing, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen collection and submission, and maintenance of accurate and complete clinical research files. Create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. Will be directly responsible for the Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending regularly-scheduled meetings (including monthly Center operations meetings). Assist PIs with proposals, progress reports and manuscripts. Independently create original documents and policies for assigned disease teams. Work closely with sponsors and federal and state regulatory officials. Oversee the recruitment and training of new personnel, including both full time employees and paid and volunteer undergraduate research assistants. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing

• Seven (7) years of relevant experience or a Bachelor's degree in a related area plus three (3) years of relevant experience.

• Clinical Trial Professional certification from a professional society within one year in position.

• Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.

• Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.

• Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.

• Critical thinking skills to evaluate issues and identify a potential solution.

• Clear and concise communicator; good verbal and written communication skills; both.

• Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.

• Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.

• Advanced degree

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