Clinical Research Coordinator Assistant

Overview The position coordinates all aspects of cardiovascular medicine clinical trials and research projects. Studies are conducted in a variety of therapeutic areas within the field of cardiovascular medicine. The assistant clinical research coordinator (ACRC) is responsible for the conduct of multiple clinical trials and research studies, including recruitment, screening, enrollment (includes administering informed consent), data collection and management, study audits and monitoring visits, study closeouts, lab specimen processing, sponsor communications, and IRB and contract/budget submissions. The ACRC maintains study datasheets/case report forms and regulatory binders and provides general tasks and support related to the departmental research program as required, such as attending research meetings and maintaining departmental databases. The ACRC must be able and willing to work in an intense cardiovascular setting and be comfortable interacting with patients. This role requires excellent verbal and written communications skills and knowledge of Good Clinical Practices (GCP) with the ability to follow GCP guidelines and applicable policies and regulations. The ACRC must be willing to receive job-related training and education as necessary, which may involve overnight travel. Minimum Qualifications Must be completed within 90 days from the date of hire. Certification of laboratory safety training must be achieved annually. Certification of the shipment of dangerous goods is required every two years. Certification from the University of California Annual Compliance Briefing for Researchers is required. High School graduation and sufficient experience and demonstrated skills to perform the assigned duties. 1 year of relevant experience, such as coordinating clinical human trials or prior research coordination experience. Ability to quickly learn and understand rules and regulations governing clinical research including “Good Clinical Practices”, federal, state, and university regulations for clinical research, and Institutional Review Board guidelines. Ability to comprehend and, under supervision, implement complex clinical research protocols with careful attention to detail and to coordinate a broad range of activities from inception to implementation within the confines of strict study protocols, university and departmental policies and procedures. Ability to exercise discretion, initiative, and resourcefulness and make independent judgments based on sound analysis. Ability to organize tasks and set priorities for work assignments to achieve timely progress on multiple tasks, meet deadlines, and maintain high productivity. Organizational skills and attention to detail in maintaining large volumes of records. Experience with or ability to quickly learn to conduct effective clinical procedures including taking vital signs, electrocardiography, and processing of laboratory specimens. Ability to learn how to effectively perform IRB regulatory work, including new study applications, annual renewals, and adverse event reports. Ability to develop administrative, analytical, and problem-solving skills for identifying and resolving problems while maintaining study protocol integrity and compliance with policies. Ability to exercise judgment, initiative, and resourcefulness in decision-making. Oral and written communication skills to clearly provide information and instructions to participants, families, physicians, clinic staff, and a wide range of health care professionals. Ability to rapidly build knowledge of anatomy, physiology, medical terminology and procedures to accurately collect data according to study protocol. Ability to perform basic accounting, calculations, and basic statistical calculations. Experience with computer word-processing programs, databases, and data management systems. Writing and printing skills to document research information clearly and concisely. Preferred Qualifications Bachelor’s in health sciences or related field preferred. Preferred prior exposure to or experience in research. Demonstrated excellent interpersonal skills for professional, courteous communication in person and on the telephone. Ability to maintain positive working relationships with faculty, community-based healthcare professionals, staff, and research participants. Skills to prepare correspondence, recruitment materials, manuscripts, contracts, and budgets. Excellent grammar, punctuation, and syntax for editing and proofreading. Excellent listening skills and ability to translate into a coherent written synopsis. Ability to protect confidential information and/or PHI as dictated by assignment, policy, or regulation. Ability to understand and navigate the organizational culture of an academic/medical department in a large public university. Knowledge of personnel, travel, and accounting policies and university procedures preferred. Key Responsibilities 50% – Data management 40% – Regulatory support and administration 5% – Finance and analytical support 5% – Administrative support Department Overview The Division of Cardiovascular Medicine is one of 13 divisions in the Department of Internal Medicine. The division includes faculty, research personnel, fellows, staff, and clinical/research teams that support cardiovascular care and study activities. Department Specific Job Scope The assistant clinical research coordinator (ACRC) will deliver high-quality clinical research care within a comprehensive cardiovascular outpatient clinic, including subspecialties in electrophysiology, heart failure, and interventional cardiology. The ACRC will provide 40 hours per week of all aspects of clinical research, including screening, consenting, and enrolling patients; participating in research procedures; conducting regulatory work (IRB submissions); administrative work; and collaborating with interdisciplinary teams. The ACRC will support multiple clinical trials and work with CVRU and senior staff as needed. This role requires strong clinical acumen, independence within a multidisciplinary team, and experience in managing complex clinical trials. Position Information Salary or Pay Range: $31.38 - $50.53 Salary Frequency: Hourly Salary Grade: 102 UC Job Title: CLIN RSCH CRD AST UC Job Code: 009336 Number of Positions: 1 Appointment Type: Staff: Career Percentage of Time: 100 Shift (Work Schedule): Four 10-hour shifts Location: North Addition Office Building (HSP002) Union Representation: RX-Research Professionals Benefits Eligible: Yes This position is 100% on-site Benefits UC Davis offers a comprehensive benefits program. See Benefits Summary for UC Davis Health Employees or UC Davis Employees for details on eligibility and plan options. The university and collective bargaining agreements govern specific benefits. For more information, visit the UC Davis Benefits pages. Physical, Environmental, and Mental Demands Physical: Standing, walking, sitting, lifting/carrying, pushing/pulling, bending, stooping, squatting/kneeling, twisting, climbing, reaching overhead, and keyboard use as described per task demands. Environmental: Chemicals, dust, gases, fumes; loud noise; humidity/temperature changes; microwave/radiation; operating vehicles and equipment; uneven surfaces. Mental: Sustained attention, complex problem solving, organization and prioritization, communication, numerical skills, and multiple concurrent tasks. Work Environment UC Davis is a smoke- and tobacco-free campus. Smoking and unregulated nicotine products are prohibited on UC Davis property, indoors and outdoors. Special Requirements This is a critical position, contingent upon successful clearing of background checks and may include drug screening, medical evaluation clearance and functional capacity assessment. This position is designated as a mandated reporter under CANRA and UC policy, with employment contingent on compliance with applicable policies and training requirements. Misconduct Disclosure Requirement As a condition of employment, final candidates will be required to disclose any final administrative or judicial decisions within the last seven years related to misconduct, or ongoing investigations or discipline involving misconduct. A Culture of Opportunity and Belonging UC Davis is an Equal Opportunity Employer. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or protected veteran status. See the University policies on Anti-Discrimination and the rationale for applying. #J-18808-Ljbffr UC Davis Health