Clinical Research Coordinator

1 month ago

Riverside, California, United States University of California Riverside Full time


Clinical Research Coordinator (0.75 FTE)

Job ID:
Location: Main Campus - UCR
Schedule: 9am to 5:30 and may include variable evenings
Category: Research and Development
Salary:
Full/Part Time: Part time
Organization: School of Medicine
Department: Pediatrics Dept
Application Deadline: Open Until Filled

Position Information:
The Clinical Research Coordinator (CRC) will perform independently or with general direction at the fully operational level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI; Dr. McGowan), the Center Research Supervisor, and/or the Center Director, Jaime Smith; the incumbent may coordinate the data collection and operations of concurrent clinical research studies under the guidelines of research protocols and regulating agency policies. This position is to serve as the Clinical Research Coordinator for a series of cross-discipline projects within the School of Medicine (SOM) Divisions of Biomedical Sciences and Clinical Sciences, with primarily focus on clinical trials sponsored by the California Institute for Regenerative Medicine (CIRM). The goals of CIRM projects under UCR's SOM is to develop infrastructure, training, and capacity for clinical trials involving cell, gene, and/or approved regenerative medicine treatments in culturally adapted and integrated ways for diverse populations across the Inland Empire.

The CRC will work 75% time (0.75 FTE) and closely with Dr. Esther Caroline McGowan and project collaborators and partners, to help coordinate and support research projects. Under the supervision of Dr. McGowan and Jaime Smith, the CRC will provide research assistance through a variety of tasks including: (1) aiding with participant recruitment, consenting, enrollment and retention; (2) coordinating community partners; (3) primary and secondary data collection and database management; (4) project management and administrative duties, including coordination of contractors and supplies; and (5) preparing reports for Institutional Review Boards, sponsors, and any other necessary reports and database management related to the research projects, including assisting with presentation and manuscript preparation.

The full salary range for the Clinical Research Coordinator is $ $52.92 per hour. We base salary offers on a variety of considerations, such as education, licensure and certifications, experience, and other business and organizational needs.

The classification title and salary range for this position are currently under review. The anticipated classification for this position is covered under the UPTE-CWA union (Research Support Professionals).

Applicants must have current work authorization when accepting a UCR staff position. Currently, we are unable to sponsor or take over sponsorship of an employment Visa for staff.

As a university employee, you will be required to comply with all applicable University policies and/or collective bargaining agreements, as may be amended from time to time. Federal, state, or local government directives may impose additional requirements.

Requirements:
Educational Requirements
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
Required Bachelor's degree or higher in research or health-related field or relevant profession, or a combination of comparable experience.
Preferred

Conditions
Must have or be able to obtain CITI Training in Human Subjects Research Protection and Good Clinical Practice immediately upon hire.
Required

Experience Requirements
At least one year of previous experience as a clinical research coordinator or equivalent combination of experience / training.
Required

Minimum Requirements
Basic knowledge of clinical research. Acquiring skills in developing and implementing research and clinical processes and systems. Communication skills; includes verbal, written and active listening. Service oriented and responsive to questions and requests. Ability to interact in a professional, resourceful, and courteous manner. Excellent computer and word processing skills, using standard software (e.g., Microsoft Office: Word, Excel, Access, Outlook, PowerPoint). Proven flexibility to adjust to constantly changing priorities. Basic knowledge of research and clinical policies and regulatory requirements. Basic knowledge of human subjects research.. Demonstrated interpersonal skills. Demonstrated ability to develop working relationships within department and with learners. Excellent organizational skills, analytical, and demonstrated attention to detail. Ability to work with complex calendars / schedules. Investigative, data analysis, and reporting skills. Ability to generate computer reports, checking for errors, correcting and submitting accurate reports. Skills include entering, maintaining, extracting, and analyzing data in electronic systems. Ability to work independently and collaboratively, with a strong capacity for self-monitoring and improvement, ability to set priorities, demonstrated punctuality, attendance, and reliability. Excellent follow-up and works well under pressure and deadlines. Bilingual - Spanish and English speaking

Additional Information:
Additional Information In the Heart of Inland Southern California, UC Riverside is located on nearly 1,200 acres near Box Springs Mountain in Southern California; the park-like campus provides convenient access to the vibrant and growing Inland region. The campus is a living laboratory for the exploration of issues critical to growing communities' air, water, energy, transportation, politics, the arts, history, and culture. UCR gives every student, faculty and staff member the resources to explore, engage, imagine and excel.

UC Riverside is recognized as one of the most ethnically diverse research universities in the country boasting several key rankings of which we are extremely proud.
  • UC Riverside is proud to be ranked No. 12 among all U.S. universities, according to Money Magazine's 2020 rankings, and among the top 1 percent of universities worldwide, according to the Center for World University rankings.

  • UC Riverside is the top university in the United States for social mobility. - U.S. News 2020

  • UCR is a member of the University Innovation Alliance, the leading national coalition of public research universities committed to improving student success for low-income, first-generation, and students of color.

  • Among top-tier universities, UC Riverside ranks No. 2 in financial aid. - Business Insider 2019

  • Ranked No. 2 in the world for research, UCR's Department of Entomology maintains one of the largest collections of insect specimens the nation. - Center for World University Rankings

  • UCR's distinguished faculty boasts 2 Nobel Laureates, and 13 members of the National Academies of Science and Medicine. The University of California is an Equal Opportunity/Affirmative Action Employer with a strong institutional commitment to the achievement of excellence and diversity among its faculty and staff. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other characteristic protected by law.

    For information about our generous employee benefits package, visit: Employee Benefits Overview

    Job Description Details:
    General Information

    Job Title
    UNCLASSIFIED

    Job Code

    Grade
    21

    Department Head
    Sasidharan Ponthenkandath

    Supervisor
    Jaime Smith

    Department Custom Scope
    The Clinical Research Coordinator (CRC) will perform independently or with general direction at the fully operational level of the series to execute, manage, and coordinate research protocols, as directed by the Principal Investigator (PI; Dr. McGowan), the Center Research Supervisor, and/or the Center Director, Jaime Smith; the incumbent may coordinate the data collection and operations of concurrent clinical research studies under the guidelines of research protocols and regulating agency policies. This position is to serve as the Clinical Research Coordinator for a series of cross-discipline projects within the School of Medicine (SOM) Divisions of Biomedical Sciences and Clinical Sciences, with primarily focus on clinical trials sponsored by the California Institute for Regenerative Medicine (CIRM). The goals of CIRM projects under UCR's SOM is to develop infrastructure, training, and capacity for clinical trials involving cell, gene, and/or approved regenerative medicine treatments in culturally adapted and integrated ways for diverse populations across the Inland Empire.

    The CRC will work 75% time (0.75 FTE) and closely with Dr. Esther Caroline McGowan and project collaborators and partners, to help coordinate and support research projects. Under the supervision of Dr. McGowan and Jaime Smith, the CRC will provide research assistance through a variety of tasks including: (1) aiding with participant recruitment, consenting, enrollment and retention; (2) coordinating community partners; (3) primary and secondary data collection and database management; (4) project management and administrative duties, including coordination of contractors and supplies; and (5) preparing reports for Institutional Review Boards, sponsors, and any other necessary reports and database management related to the research projects, including assisting with presentation and manuscript preparation.

    *The classification title and salary range for this position are currently under review. The classification for this position is covered under the UPTE-CWA union (Research Support Professionals).**

    Key Responsibilities:
  • Study Implementation and Human Subjects Coordination:
    Identify subjects, recruitment, and enrollment of study participants ensuring adherence to the study inclusion/exclusion criteria. Provide informed consent to interested and qualified study participants, reviewing consent forms, discussing all aspects of study participation, answering questions, assessing comprehension, and ensuring all consents are completed thoroughly and appropriately with dates and signatures of/with potential participants. Ensure that the consent process is ongoing and continues through the study including by amending consent forms and re-consenting as appropriate as well as documenting, distributing, and filing consent forms appropriately. Provide potential participants with the Experimental Subject's Bill of Rights and HIPAA documentation when necessary. Schedule and maintain participant study visits including associated documentation and following appropriate study procedures. Protect the rights and welfare of human subjects. Maintain subject tracking systems. Manage lab specimens for processing and shipping. Participate in the review and modification of study protocols to adapt to the needs of the study. Design and enhance data collection forms as needed; continue to develop and maintain systems for assuring protocol adherence and data quality. Review case report forms and source documents for adverse events. Review and modify data collection instruments including case report forms ensuring accuracy and completeness. Organize and update implementation manuals and other study-specific source documents.
  • 50%

  • Research and Regulatory Support: Read and understand all regulatory, institutional, and sponsor requirements for each study and comply with all decisions, conditions, and requirements. Review study protocols and other materials (e.g., Investigators Brochure, data collection forms and sample consent forms) for understanding and complying with procedures and safety. Complete and maintain human subjects protection CITI training and all sponsor required training. Maintain all study and sponsor training documentation for all research staff and affiliates. Set up and organize study files. Develop, manage, and submit all sponsor and IRB documents, revisions, and renewals including consents and study protocols. Obtain translations of study documents as necessary. Serve as a liaison between IRB, sponsor, and study Investigators. Seek assistance on maintaining all protocols by communicating with IRB analysts. Assure studies are carried out according to Code of Federal Regulations, Good Clinical Practice, sponsor,and UCR regulations. Make sure all studies have current IRB approvals before any study procedure is initiated. Capture and report adverse events and protocol violations to the study PI, the IRB, and the study sponsor. Use sound judgment to maintain participant confidentiality when communicating with agencies, healthcare providers, other studies, and outside departments, ensuring that PHI will not be reused or disclosed to any parties other than those described in the IRB-approved protocol, except as required by law. Schedule, facilitate, and attend site-initiation meetings and monitoring visits. Participate in and cooperate with any internal and external audits or reviews of study protocols and procedures; prepare necessary documentation. Update and maintain a procedure manuals documenting all study-related procedures; help develop a plan to ensure consistency in data collection and data entry.
  • 40%

  • Data Management and Reporting: Collect data during subject visits when appropriate. Data entry into various research and clinical systems including but not limited to REDCap, Qualtrics, MS Excel, MS Access, measure specific software, reference management applications, and EPIC. Oversee data integrity. Maintain participant enrollment database and subject tracking systems. Manage database structure for each protocol; update databases to improve data analysis and management; create new databases as needed. Create and maintain comprehensive data sets. Maintain data collection forms for effective data collection, entry, and analysis. Perform queries and analyses in databases. Work with Supervisor to maintain complete and accurate data in the study database; analyze the data as they become available.
  • 5%

  • Administrative: Train and support other personnel involved in the study on research protocols, changes in procedures, study protocols, data collection/entry, database procedures, and other procedures. Create, purchase, organize and maintain documents, supplies, and materials for research studies, assessing that study logistical and resource needs are met. Oversee subject reimbursement; work to resolve discrepancies and issues. Create and maintain MOUs and community partner contracts and letters of support. Coordinate, communicate, and network with other departments, studies, personnel, and stakeholders; communicate with any affiliated groups. Provide manuscript feedback. Coordinate, prepare for, schedule, attend, and actively participate in team meetings.
  • 5%

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