Clinical Research Coordinator - Pathology - 141777

The Center for Perinatal Discovery (CPD) is a collaboration between the Departments of Pathology, Obstetrics, Gynecology, and Reproductive Sciences, and Pediatrics. The CPD was established to promote research into perinatal health, including the health of both mothers and babies. To this end, the CPD is conducting research studies into both maternal and neonatal health. Clinical data and biospecimens are being collected at several clinical sites from normal and high-risk pregnancies, with neonatal/pediatric follow-up. The CPD is also involved in community educational activities which promote maternal and child health.

Incumbent will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects within the Perinatal Pathology division for the Center for Perinatal Discovery (CPD), coordinating studies related to placental function as related to adverse pregnancy and neonatal outcomes. Create informational and recruitment materials and act as a liaison with OBGYN, Neonatology, and other departments and agencies for the purpose of implementation of studies. The Clinical Research Coordinator will plan, develop, and implement start-up procedures for observational clinical research studies as well as lead, direct, and coordinate operational efforts, biospecimen collection as needed, transport, and processing. Assure compliance with state and federal regulatory guidelines, serving as the main regulatory personnel writing and submitting human subjects protocols, amendments, renewals, and safety reports. Oversee the quality of the medical, clinical research, and data collection, applying appropriate analytical methods as needed. Provide direction and guidance to clinical and research faculty, trainees, and undergraduate volunteer research assistants. Provide education and information to the general public concerning ongoing clinical research. Assist PIs with proposals, grant applications, progress reports, abstracts, and manuscripts. Independently create original documents and policies for assigned division, and represent the PI at internal and external study-specific meetings. Work closely with federal and state regulatory officials.

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

• Demonstrated experience in clinical research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.

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

• Strong knowledge of clinical research protocols and study procedures (data management, query resolution, protocol design and protocol implementation).

• Proven ability to problem solve and resolve conflict.

• Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.

• Proven ability to work with human tissues, processing and biobanking.

• Strong experience in providing work direction and assisting supervisor in maintaining an efficient research team.

• Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.

• Ability to discern items that can be handled independently and those which require attention of supervisor, including ability to quickly determine subject matter of material and necessary action to be taken in a timely manner.

• Working knowledge of medical and scientific terminology.

• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.

• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.

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

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and/or Bloodborne Pathogens.

• Strong experience with study subject recruitment and/or coordinating research study start-up activities.

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

• 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.

• Ability to work independently. Ability to maintain confidentiality.

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

• Knowledge of laboratory, pathology, and other diagnostic procedures.

• Possess a Clinical Research Coordinator Certificate, or Masters Degree in related field.

• Experience working with research bulk accounts.

• Phlebotomy certification.

• Must be able to work various hours and locations based on business needs.
• Employment is subject to a criminal background check.
• Employment is subject to pre-employment physical for those who work in clinical settings and/or with patients.
• Performs other duties as assigned.
• Complies with all policies and standards.
• Complies with the University of California, San Diego Health (UCSDH) Principles of Community.
• This position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.