Clinical Research Coordinator 1

Job Summary The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines. Job Responsibilities Performs chart review/pre‑screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to protocol. Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, scheduling appointments and study visits, meeting scheduling, and project evaluation. Performs moderate to complex research tests/experiments and adapts procedures for quality improvement under supervision. Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur. Assists in observing and informing the PI/supervisor of adverse events reported by study participants. Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study. Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies. Knows the contents and maintenance of study‑specific clinical research regulatory binders. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Adheres to University and unit‑level policies and procedures and safeguards University assets. This list of duties and responsibilities is not intended to be all‑inclusive and may be expanded to include other duties or responsibilities as necessary. Department Specifics Assists the Monitors and PIs in the organization and preparation of Site Initiation Visits (SIV) and in providing the patients and their families with a thorough description of the research protocol. Attends site disease group tumor board meetings and site disease group collaborative meetings. Assures that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner. Compiles patient data and presents those to the PI for their determination of patient eligibility for protocol enrollment. Ensures eligibility forms are completed as required. Assists PI in obtaining informed consent and documents the informed consent process as required. Enters required protocol enrollment report to CRIS Office and JHS CTO according to established procedures. Completes and submits protocol specific forms as required per UM and/or JHS policies. Ensures study protocol adherence, including completion of protocol specific procedures and the completion of protocol specific documents while obtaining relevant medical information from patient clinic charts/medical records. Maintains/logs progress reports to track both currently enrolled as well as follow‑up participants. Provides protocol specific study documentation required in the management of study patients as per the protocol, federal regulations, sponsor requirements, SOPs and UM policies while maintaining logs to track progress reports to both currently enrolled as well as follow‑up participants. Enters data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy. Executes the plan developed for collection of protocol specific subject specimens, i.e. pharmacokinetics samples, blood specimen, tissue samples, etc. as per protocol. Ensures that protocol lab kits and study specific supplies are obtained/ordered as necessary. Responsible for the entry of and maintenance of the patient calendars. Ensures protocol specific data is entered into Velos. Monitors adherence to protocol. Takes action to report and correct deviations or other problems. Records and reports AEs, SAEs and UPs in compliance with federal regulations, the protocol and UM policies to the sponsor and/or IRB as directed by the PI. Maintains logs including but not limited to screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs and actively participates in monitoring visits and site audits. Ensures that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH‑GCP, and federal regulations. Establishes and maintains contact with patients/participants, health care providers, community agencies, study sponsors. Updates appropriate agencies such as sponsors, IRB, etc. regarding current status of research projects as required and under the supervision of the PI. Updates SCCC Business Office staff as requested about patient accruals/completed cycles for billing of Industry Studies and for calculation of RVUs for in‑house studies and provides support with study related procedures as required, i.e., EKG, laboratory and tumor assessment studies. Ensures timely IRB submissions of initial protocol, continuing reports, amendments, IND safety reports, AEs, SAEs, UP, deviations, etc. with support from the Sr. Regulatory Specialist. Communicates all IRB and Sponsor related approvals, changes, information, etc. to the PI and study team and adapts to physician schedules to perform protocol specific patient visits and/or procedures including, but not limited to early AM and/or early evening hours as required. Participates in a collaborative, empowered work environment as demonstrated through teamwork and ensures work environment is organized and functions efficiently. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center and provides coverage for other CRS SDGs as needed. Benefits The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. Qualifications Education: Bachelor’s degree in relevant field required Experience: Minimum 1 year of relevant experience Skill in completing assignments accurately and with attention to detail. Ability to analyze, organize and prioritize work under pressure while meeting deadlines. Ability to process and handle confidential information with discretion. Ability to work evenings, nights, and weekends as necessary. Commitment to the University’s core values. Ability to work independently and/or in a collaborative environment. Equal Opportunity Employer The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Job Status Full time Employee Type Staff #J-18808-Ljbffr