DESCRIPTION

Department of Pediatrics is one of the largest departments within the UCSD School of Medicine with comprehensive clinical programs, extensive basic science and clinical research, and diverse educational opportunities for students, residents and fellows. The internationally renowned faculty play a major role in medical and graduate student training, providing educational and programmatic offerings that span several disciplines, and provide diversity to meet the interests of a broad spectrum of students and scholars. More than one hundred trainees at the graduate student and postdoctoral level, as well as more than 300 professional, research and administrative staff who along with the department administrators interact closely with the faculty. The diverse mix of ages, backgrounds, and talents creates a robust work environment with challenging career opportunities and a commitment to continued growth potential. We constantly seek to recruit highly motivated, technologically-advanced and interested individuals to become a part of our dynamic cutting-edge research, clinical, and educational environment.

Under full supervision, the Clinical Research Consortia Coordinator (Consortia Coordinator) coordinates Consortia activities at the coordinating center as it pertains to Consortia protocols and clinical trials in conjunction with Consortia personnel and Medical Director. The Consortia Coordinator will prepare, submit, and maintain regulatory approvals, setup and maintain regulatory binders for participating sites, coordinate site initiation visits and site activation, coordinate study meetings and record meeting minutes, and serve as the liaison with participating sites for any protocol related issues such as clarifications and compliance. The incumbent demonstrates attention to detail the ability to prioritize and handle multiple tasks/projects. The he Consortia Coordinator demonstrates critical thinking skills and has the ability to analyze and troubleshoot issues as they arise. Additionally, the incumbent must demonstrate interpersonal skills necessary to work effectively with external participating sites, ancillary staff & research team; must demonstrate strong written and oral communication skills, and posses excellent phone & e-mail etiquette.

The Consortia Coordinator will also be responsible for coordinating and managing clinical trials when UCSD is a participating site of a Consortia study, including providing all aspects of protocol management such as screening for patient eligibility, informed consent, data collection and analysis, sample collection and transport between institutions, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. The incumbent is responsible for Institutional Review Boards (IRB) formatting and submission of all relevant material, UCSD IRB renewals and safety reports. Directly communicates with assigned physicians and nurses, attending regular Divisional and collaborative research meetings. The Consortia Coordinator will perform sample collection and analysis in conjunction with CPD and the Division of Hematology investigators' lab(s). Performs other duties as assigned.

MINIMUM QUALIFICATIONS

• Theoretical knowledge of biology, microbiology, social sciences or related field, as typically attained by a Bachelor’s degree and/or an equivalent combination of education and experience.

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

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

• Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), IRB, IATA Shipping of Blood Specimens, and Bloodborne Pathogens.

• Experience with clinical trials participant or study subject recruitment.

• Experience coordinating study startup activities.

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

• Knowledge of x-rays, scans, and other diagnostic 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.

• 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.

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

PREFERRED QUALIFICATIONS

• Experience working with research bulk accounts.

• Experience with investigational drug authorization criteria.

• Experience with data management tools such as REDCap.

• Experience collecting, processing, and analyzing tissue samples in a lab setting.

• Experience with and understanding of basic laboratory equipment.

• Experience working with FDA policies regulating clinical trials.

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

SPECIAL CONDITIONS

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

• This is a remote position but may require occasional travel to consortia meetings.

• May also require travel to different site locations and work on weekends and evenings.

• May require travel between sites (Jacobs Medical Center, Rady Children's Hospital, Rady Children's Hospital satellites, and campus lab space).