Clinical Research Specialist

The salary range for this position is $5,750.00 – $6,250.00 per month depending upon qualifications.

This position is open until filled with the first review of qualified candidates 2 weeks after initial posting.

Project Overview

At San Diego State University's (SDSU’s) HealthLINK Center for Transdisciplinary Health Disparities Research (SDSU HealthLINK Center), our vision is to inspire transformational and collaborative research that promotes health and well-being for all people and communities. Fundamental to our mission is the advancement of health equity. Our collective efforts are driven by a diverse and multi-disciplinary team that includes wide-ranging expertise at all levels of our organization. We are based a short 1.2 miles off the SDSU campus and benefit from the culture of diversity and inclusion that SDSU offers.  We offer comprehensive benefits that support the overall well-being and quality of life of our employees.

Funded by the National Institute on Minority Health and Health Disparities through a U54 Cooperative Agreement, the SDSU HealthLINK Center offers a wide range of research services, housing expertise in multiple research methods, supporting varied research needs, and data analytics applications across the university to enhance health disparities research. The SDSU HealthLINK Center is designed to support research projects led by SDSU, SDSU IV, and SDSURF investigators, affiliated partner organizations, and industry partners, including those funded as Center Research Projects, as Pilot Projects, or who access our services through a cost recovery system.  

Purpose of the Position

The Clinical Research Specialist (CRS) will serve as a key member of the Center’s Executive Team, working under the direction of the Deputy Director, and receiving high-level guidance from the Center Research Manager, the Clinical Lab Director, and the MPIs. The CRS will support multiple research projects involving human subjects within the Center’s Clinical Research space. They will provide guidance and consultation support to clinical and/or behavioral trial projects and ensure project compliance with the goals and objectives of research protocols and with state and federal regulatory guidelines. This role involves ensuring the proper regulation of human subjects research and providing training and consultation to researchers. The CRS will also support the operational, legal, and regulatory aspects of the Center’s facilities and equipment.

Specific Duties

The Clinical Research Specialist (CRS) is responsible for:

• Coordinate with the Center’s Clinical Lab Director & Research Manager and support establishing the Center’s Clinical Laboratory Improvement Amendments (CLIA) waiver certification application and implementation process. 
• Assist with the development of the Center’s Human Subjects Research Ethics training and consultation program
• Develop and support the implementation of the clinical protocols for Research Projects, Pilot Projects, and cost-recovery service users supported by the Center. 
• Develop, implement, and support scopes of work for research activities within the Clinical Research Center space.
• Support the establishment of new research services within the Clinical Research Center spaces. 

• Implement scopes of work for research activities occurring within the Clinical Research Center space. 
• Ensure projects are conducted, recorded, and reported following project protocols, Standard Operating Procedures, Good Clinical Practices, FDA, HIPAA, and any other applicable regulatory requirements
• Monitor clinical trials and document deviations from standard procedures.
• Oversee the SDSU HealthLINK Center RealTime Clinical Trial Management System (CTMS) for new user/study setup, training, project implementation, and project closeout.
• Coordinate, with the Center Research Manager, to support all Clinical Research Center space use, including maintaining physical spaces and equipment. 
• Collaborate with the Research Manager and other Coordinators, develop and maintain policies and procedures related to the use of Clinical Research Center facilities.
• Train team members on operational and safety policies and procedures to ensure appropriate use of spaces and equipment 
• Provide career enhancement workshops on clinical research best practices, in collaboration with the other teams within the Center.
• Coordinate the Center’s Human Subject Research Ethics training and consultation program.
• Train Pilot Project Investigators in developing informed consents, project protocols, adverse event monitoring procedures, and data safety and monitoring plans.
• Serve as point of contact for Research Projects and Pilot Projects on regulatory issues.
• Assist Research and Pilot Projects with preparing regulatory binders, manuals of procedures (MOP), initial data safety and monitoring board (DSMB) protocols, and ongoing progress reports and files on the SDSU HealthLINK Center RealTime Clinical Trial Management System (CTMS).
• Support the annual renewal efforts to maintain/update the Center’s CLIA waiver certification.
• Ensure all operational, legal, and regulatory documents are filed and comply with applicable laws, regulations, and institutional policies.
• Coordinate, with the Center Research Manager, to support all Clinical Research Center space use, including maintaining physical spaces and equipment. 

• Present at the Center’s National Advisory Committee meetings. 
• Support the Center’s annual reporting to the funder. 
• Supervise students and volunteer interns.
• Attend trainings and meetings, including all Center meetings and RCC Coordinator Status meetings.
• Comply with all Center, SDSU, SDSU IV, and SDSURF policies and procedures.

Qualifications

• Working knowledge of medical and scientific terminology
• Knowledge and experience of the clinical research setting, including protocols, principles, and standards.
• Demonstrated experience planning and performing clinical research studies. 
• Demonstrated ability to accurately collect, record, transcribe, and synthesize clinical data while paying conscientious attention to details. Experience creating and completing clinical trial forms via hard copy and/or online. 
• Ability to understand and interpret complex research protocols to screen patients for eligibility, initiate study plans, collect data, and evaluate for adverse events and protocol deviations. 
• Experience with handling laboratory samples and knowledge of shipping procedures. 
• Knowledge of Human Subjects Protection requirements. 
• Ability to develop and submit protocols and amendments to regulatory agencies and organizations (Institutional Review Boards, DSMBs) for human subjects research.
• Experience with clinical trial registry sites, such as Clinicaltrials.gov and others
• Demonstrated ability to work with different clinical protocols concurrently. 
• Ability to understand and learn study procedures from protocols. Ability to problem-solve. 
• Skills in administering study-related questionnaires and assessments.
• Ability to communicate to supervisor and research teams about study progress and accept constructive advice and suggestions. 
• Strong interpersonal communication skills and ability to work well with a variety of contacts in the health care and research fields.
• Ability to maintain confidentiality following Personnel and Human Subjects requirements.
• Ability to perform multiple tasks efficiently, ability to work in a research office setting.
• Ability to efficiently understand, organize, prioritize, and meet deadlines as required.
• Ability to follow through on assignments with attention to detail.
• Ability to work with a diverse group of professionals, including physicians, other health care professionals, and research subjects. 
• Experience working with Clinical Trial Management System software, such as RealTime.
• Computer experience including Microsoft Office, database management, and email skills.
• Experience conducting workshops, webinars, and other types of training.
• Excellent (or professional) written and oral communication skills, including English grammar, spelling, and punctuation.
• Ability to display flexibility and handle multiple work priorities and interruptions.
• Well organized, able to meet deadlines, detail-oriented, possess good judgment and common sense.
• Ability to work variable hours, including late afternoons/evenings and some weekends, as needed for activities in the community.
• Demonstrate a high level of cross-cultural sensitivity.

• Equivalent to a bachelor’s degree in appropriate field related to program/project, or additional experience may be substituted for the required education on a year for year basis.
• Four years of progressively responsible experience in technical or administrative assignments, two years of which would be at the Program Specialist I level.

ADDITIONAL APPLICANT INFORMATION

• Candidate must reside in California and live in a commutable distance from SDSU at time of hire.
• Job offer is contingent upon satisfactory clearance based on Brackground Check results (including a criminal record check).
• San Diego State University Research Foundation is an EEO/AA/Disability/Vets/Title IX Employer.

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