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#105091 Assistant Clinical Research Coordinator

Company: University of California - San Diego Medical Cente
Location: San Diego
Posted on: November 23, 2020

Job Description:

#105091 ASSISTANT CLINICAL RESEARCH COORDINATOR

Filing Deadline: Thu 12/3/2020

UCSD Layoff from Career Appointment: Apply by 07/27/20 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 08/06/20. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.

Reporting directly to director of cardiovascular clinical research. Responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, 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. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing.

Under supervision, the Clinical Research Coordinator Ast. will be assigned to coordinate multiple federally funded and industry sponsored research studies involving human subjects that are being conducted in the UCSD Cardiovascular Institute and at other local locations. Assist with initiation, implementation and management of clinical trials. Ensure compliance with goals and objectives of research protocols and with state and federal regulatory guidelines. Duties include but not limited to: interpreting research protocols; recruiting subjects; screening for eligibility including obtaining vital signs, ECGs, height and weight; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects visits; coordinating clinical, laboratory and data activities; processing and submitting laboratory specimens; collecting and entering research data; maintaining accurate and complete clinical research files and patient medical charts.

Update study and patient records in the University approved Clinical Trial Management System (VELOS) on a consistent basis. Working directly with Human Research Protection Program (HRPP), submitting new protocol applications, amendments, safety reports and annual renewals, as needed. Act as liaison between the Principal Investigators, the HRPP and study sponsors.

MINIMUM QUALIFICATIONS

*

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 performing clinical research duties in a clinical research environment.
*

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

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

Demonstrated experience working with FDA policies regulating clinical trials.
*

Proven experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
*

Proven experience maintaining files and keeping records. Experience completing clinical trials case report forms via hard copy and online.
*

Demonstrated 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), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
*

Demonstrated experience with clinical trials participant or study subject recruitment.
*

Demonstrated experience coordinating study startup activities.
*

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

Thorough knowledge of x-rays, scans, and other diagnostic procedures.
*

Strong planning and organizational skills. 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, written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills.
*

Ability to interact effectively with diverse groups, including professional and non-professional staff and clients. Ability to work independently. Ability to maintain confidentiality.

PREFERRED QUALIFICATIONS

* Certification as a Clinical Research Associate or Coordinator.

* Experience in a Cardiology research setting is highly preferred.

* Experience working with research bulk accounts.

* Experience with investigational drug authorization criteria.

SPECIAL CONDITIONS

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

* Occasional evenings and weekends may be required.



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!



Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.



UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

Keywords: University of California - San Diego Medical Cente, San Diego , #105091 Assistant Clinical Research Coordinator, Healthcare , San Diego, California

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