#132546 Clinical Research Coordinator - Remote
Filing Deadline: Thu 10/17/2024
UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.
UCSD Layoff from Career Appointment: Apply by 10/07/24. for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 10/17/24. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Please note that this position is a part-time appointment. This position has the option of working a hybrid or remote schedule.
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, fellows and postdocs and 480 staff personnel.
This position will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. Create informational and recruitment materials and act as a liaison with other UCSD departments and agencies for the purpose of implementation of studies. The Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned disease team as well as lead, direct, and coordinator operational efforts. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Independently create original documents and policies for assigned disease teams. Work closely with federal and state regulatory officials.
Oversee Clinical Trials Administration and Regulatory compliance, coordination and documentation of specified pharmaceutical and device clinical trials and protocols. Responsible for development of protocols and execution of procedures. Responsible for ensuring that all procedures comply with regulatory procedures and standard operating procedures. Design case report forms for PI initiated and Sponsor provided protocols.
Responsibilities include the development and maintenance of all study related documents and procedures for the FDA, CRO and Pharmaceutical Company; oversee execution of protocols to be conducted at the site; and coordinate, assign, and evaluate the activities of in-house coordinating staff to ensure FDA Compliance and Good Clinical Practice. This position will require developing, updating and refining of Standard Operating Procedures. Additionally, responsible for study recruitment, including the innovation of screening process to improve patient and clinical trial databases. Responsible for performing protocol defined procedures as required. Independently collect and analyze scientific data for publication, identify and develop new clinical trial protocols, train and monitor research staff, medical students, fellows, hospital nurses assigned to these protocols. Incumbent is required to use Velos, a mandatory clinical trials management system that is used to track all patients enrolled in a clinical trial, track all scheduled visits and individual events performed at each visit and is used for studies that have a conventional care coverage analysis. Other duties assigned as needed.
Minimum Qualifications
- Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.
- Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.
- Demonstrated experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.
- Demonstrated experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.
- Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.
- Strong knowledge of investigational protocols especially with cardiology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).
- Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
- Strong experience completing clinical trials case report forms via hard copy and online.
- 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.
- Working knowledge of medical and scientific terminology.
- Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail.
- Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.
Preferred Qualifications
- Possess a Clinical Research Coordinator Certificate, or Masters Degree.
SPECIAL CONDITIONS
- Employment is subject to a criminal background check and pre-employment physical.
- Occasional evenings and weekends may be required.
Pay Transparency Act
Annual Full Pay Range: $74,792 - $120,269 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent: $35.82 - $57.60
Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).
If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.
If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!
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