UCLA Clinical Research Coordinator Job Description: A Comprehensive Overview

Clinical research coordinators are vital to the successful execution of clinical trials and research studies. At UCLA Health, these professionals play a key role in advancing medical knowledge and improving patient care through meticulous planning, coordination, and management of clinical research activities. This article provides a detailed job description for a Clinical Research Coordinator at UCLA, outlining the responsibilities, required skills, and the overall impact of this role within the institution.

Overview of the Clinical Trials Coordinator Role

The Department of Urology at UCLA Health is seeking a full-time Clinical Trials Coordinator to contribute to its research endeavors. This position involves direct responsibility for implementing research activities across various studies, including multi-center clinical trials sponsored by the NIH and industry, local investigator-initiated clinical trials, and programmatic clinical research activities. The coordinator is expected to manage projects effectively, prioritize tasks, and ensure adherence to study protocols and regulatory guidelines.

Work Details:

Location: Los Angeles, CA
Job Number: 26790
Work Hours: Monday-Friday, 8 am-5 pm (hours may vary)
Employment Type: Staff- Career, Indefinite Duration
Bargaining Unit: UPTE - RX

Key Responsibilities

The Clinical Research Coordinator is responsible for managing all aspects of research activities, ensuring projects are completed on time and in compliance with institutional policies, FDA regulations, and ICH Good Clinical Practice (GCP) guidelines. Key responsibilities include:

Project Management: Planning and organizing tasks to meet deadlines and ensure adherence to study protocols and applicable regulations.
Regulatory Compliance: Ensuring adherence to institutional policies, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP).
Study Coordination: Implementing and managing research activities for one or more studies, including multi-center clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities.
Collaboration: Working closely with the Principal Investigator (PI), research teams, sponsors, and institutional departments to ensure successful study conduct.
Financial Oversight: Managing financial aspects of the study, ensuring proper support across all phases of research.

Detailed Responsibilities and Expectations

Clinical Research Coordinators provide support, coordination, and leadership for FDA-regulated drug/device studies. These studies may include industry-sponsored Phase I, II, III, and IV clinical trials, government-funded clinical research, and investigator-initiated clinical research (collectively referred to as “clinical research involving human subjects”). They ensure the smooth, accurate progress of clinical studies from the planning and approval stages through study completion and post-study closure.

Specifically, the responsibilities of a Clinical Research Coordinator at UCLA Health encompass the entire lifecycle of a clinical study, from initiation to closeout. This includes:

Study Planning and Initiation

Protocol Development Assistance: Collaborating with the principal investigator (PI) in the development of study protocols, ensuring feasibility and adherence to regulatory requirements.
Budget Preparation: Assisting in the preparation of study budgets, including forecasting expenses related to patient care, data management, and other research-related activities.
IRB Submission: Preparing and submitting study-related documents to the Institutional Review Board (IRB) for review and approval, ensuring compliance with ethical guidelines and regulatory standards.
Site Initiation Visits: Participating in site initiation visits conducted by sponsors, ensuring that all study personnel are adequately trained and prepared for study conduct.

Study Conduct and Management

Patient Recruitment and Enrollment: Implementing recruitment strategies to identify and enroll eligible patients into clinical trials, ensuring informed consent is obtained and documented appropriately.
Data Collection and Management: Collecting and managing study data, maintaining accurate and complete records, and ensuring data integrity and security.
Adverse Event Reporting: Identifying and reporting adverse events (AEs) and serious adverse events (SAEs) to the appropriate regulatory authorities and sponsors, ensuring patient safety is prioritized.
Study Monitoring: Coordinating study monitoring visits conducted by sponsors, addressing any issues or concerns raised during the monitoring process, and implementing corrective actions as needed.
Regulatory Compliance: Ensuring compliance with all applicable regulations and guidelines, including FDA regulations, ICH guidelines, and UCLA institutional policies.

Study Closeout

Data Archiving: Preparing and archiving study-related documents and data in accordance with regulatory requirements and institutional policies.
Final Report Preparation: Assisting in the preparation of final study reports, summarizing study findings and outcomes for dissemination to the scientific community.
Audit Readiness: Ensuring that all study-related documents and data are audit-ready, facilitating inspections conducted by regulatory authorities or sponsors.

Levels of Clinical Research Coordinators

Within the Clinical Research Coordinator job family, there are typically different levels based on experience and expertise. These levels may include:

Assistant Clinical Research Coordinator: Performs entry-level duties related to the support and coordination of clinical studies under full supervision.
Clinical Research Coordinator: Independently or with general direction, performs one or more of the functions described above at the fully operational journey level.
Senior Clinical Research Coordinator: Independently coordinates and is accountable for the overall administration and outcome of one or more clinical studies, typically requiring advanced-level knowledge and skills.

These positions are generally non-exempt.

Skills and Qualifications

To be successful in this role, candidates should possess the following skills and qualifications:

Education: A bachelor's degree in a related field (e.g., life sciences, healthcare) is typically required.
Experience: Prior experience in clinical research is highly desirable.
Knowledge: A strong understanding of clinical research principles, FDA regulations, and ICH Good Clinical Practice (GCP) guidelines.
Skills:
- Excellent organizational and time-management skills.
- Strong attention to detail.
- Ability to prioritize multiple projects and meet deadlines.
- Excellent communication and interpersonal skills.
- Proficiency in data management and analysis.
- Ability to work independently and as part of a team.

The UCLA Health Environment

UCLA Health is committed to fostering a nurturing and inclusive environment that promotes professional growth and teamwork. Employees describe the environment as welcoming, friendly, and supportive, with opportunities for sharing ideas and making a meaningful impact.

Employee Testimonials:

VINCENT, Sr. MONICA: "The environment is nurturing and fosters growth… I've been blessed to touch so many lives through my serving. It's a privilege to uplift other employees with words of encouragement and a smile."
SOZIT: "The first thing I noticed when I joined the team was how everyone is very welcoming and friendly with supportive management. I did not feel like an outsider."
EDGAR: "Once I joined, I knew UCLA Health was THE place to be due to the growth potential and training offered."
RENE: "If you want to grow professionally, this is the right place for you."
ERA: "We are family here. We support each other. We collect together."
ELIZABETH: "It’s so diverse and inclusive here. There’s always the opportunity to share your thoughts. It's a place where you feel you belong."
JERRY: "Your career path at UCLA Health will enable you to follow a myriad of avenues and turns. It opens up a wide variety of opportunities."
ORLANDO: "There’s a togetherness and higher level of commitment to teamwork at UCLA Health. We are several groups and teams that work together with a common goal which is to improve our patients' experience."
DAVID: "UCLA Health walks the walk and talks the talk! It's an incredible feeling to work for an organization that always puts the patient first. I am honored to work in full alignment with the UCLA Health Mission and Vision."
DR. ISLA GARRAWAY: "UCLA has incredible resources and a team science approach. The ability to work with collaborative teams and access the amazing resources around campus is the best part about being at UCLA."
RADU: "UCLA is very diverse in its personnel as well as its many research fields studied."
JENNA: "UCLA Health provides so many opportunities to exchange ideas, share moments, and grow. I have learned a lot about team management and relationship building."
SHARON: "I was looking for a job to further my career and continue to improve and learn as a therapist."
TARO: "I have been blessed to be surrounded by supportive colleagues who aspire me to be the best version of myself."

These testimonials highlight the supportive and collaborative culture at UCLA Health, making it an attractive place to work for those seeking professional growth and a sense of belonging.

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Importance of the Role

The Clinical Research Coordinator role is crucial for the advancement of medical knowledge and the improvement of patient care. By ensuring the integrity and compliance of clinical trials, these professionals contribute to the development of life-saving breakthroughs, innovative therapies, and next-generation technologies. Their work directly impacts the lives of people around the world.

Avenues and Turns in Your Career Path

UCLA Health offers a wide variety of opportunities for career advancement. The Clinical Research Coordinator role can lead to various paths within the organization, including:

Clinical Research Manager: Overseeing multiple clinical research studies and managing a team of research coordinators.
Regulatory Affairs Specialist: Focusing on regulatory compliance and ensuring adherence to FDA regulations and guidelines.
Clinical Data Manager: Managing and analyzing clinical trial data, ensuring data integrity and accuracy.
Research Scientist: Conducting independent research and contributing to the development of new therapies and treatments.

Recruitment Scam Alert

It is important to be aware of recruitment scams targeting UCLA Health applicants. Scammers may request personal information or money to allegedly progress the application or pay for work permits. These communications are fraudulent and do not originate from UCLA Health.

Please note:

UCLA Health will never ask for money or payments from applicants at any point in the recruitment process.
All individuals who receive an employment offer from UCLA Health will be required to go through a formal recruitment process, which will always involve a virtual or in-person meeting with a UCLA Health employee or representative.
Do not disclose your personal or financial details to anyone you do not know.

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