Description

The Semel Institute is seeking to hie a full time Senior Clinical Research Coordinator to complete the duties of Sr. Study Coordinator. Duties in this role will consist of Clinical research Coordination, Data and Regulatory Management, Training and Development, and lastly Services Excellence. Daily task in this role can include:

• Independently manage a portfolio of studies including complex studies such as multi-center clinical trials and/or investigator-initiated trials

• Providing financial queries and supporting UCLA required clinical trial functions such as OnCore data entry, response to financial queries, request and review of Beacon/non-cancer order templates, etc.

• Manage and resolve sensitive patient and customer services related issues, providing guidance to staff as needed

• Coordinate research studies, identify participants according to the IRB approved recruitment plan and assist the PI with determining patient eligibility.

• Facilitate the informed consent process, communicate protocol requirements to the participant, provide participant education related to protocol requirements and the significance of protocol compliance.

• Complete, organize and maintains all documentation required by the Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Good Clinical Practice (GCP) Guidelines, or the funding source.

• Procure and distribute required study supplies to the appropriate sites for study start-up and ongoing study needs. Including Coordination of specimen collection & shipping biospecimens.

• Collect information for adverse event (AE) or serious adverse event (SAE) reporting to review with the Investigator and facilitates reporting requirements to applicable stakeholders (DSMB, IRB, funding source).

• Assist in developing the study informed consent form(s) and amending the informed consent form(s) as applicable.

• Ensure timely regulatory reporting and thorough documentation.

• Provides training and oversight for developing clinical research coordinators - mentors developing clinical research coordinators to work independently and critically think through issues and challenges

• Participates in quality improvement initiatives, quality control, development of SOPs, formulating strategies, etc.

Pay Range: $82,713.61 - $133,060.10 annually Qualifications

Required:

• Bachelor's degree required

• Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.

• Ability to effectively communicate to and interact with patients in a compassionate and kind manner.

• Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.

• Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.

• Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.

• Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met.

• Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.

• A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.

• Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.

• Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to understand manner.

• Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines.

• Ability to handle confidential information with judgement and discretion.

• High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual.

• Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc.

• Strong knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.

• Strong knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. Ability to think creatively to develop solutions affecting the full team.

• Experience with FDA processes and procedures.

• Sufficient experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets.

Preferred:

• Master's degree preferred.

• Minimum of 4+ years of experience in a clinical research setting.

UCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person’s unique achievements and experiences to further set us apart.