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|Clinical Research Coordinator 1|
Company: University of Miami
Location: Miami, FL
Employment Type: Full Time
Date Posted: 08/17/2022
Expire Date: 10/17/2022
Job Categories: Healthcare, Other
Clinical Research Coordinator 1|
The Clinical Research Coordinator 1 will assist the Principal Investigator in the conduct all aspects of the clinical trial, including regulatory tasks, under the direct supervision of the Principal Investigator, and Clinical Research Manager. The CRC provides operational and administrative support in the management of patients accrued to multiple research protocols to assure subjects’ safety and regulatory compliance. The CRC is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, Standard Operating Procedures and all applicable regulations and guidelines and ensuring effective data flow associated with research protocols. The CRC is critical to ensuring the safety of patients enrolled on a clinical trial. Patient duties include but are not limited to: Meeting with the patient in clinic and providing information on the specific clinical trial; answering the patient questions and facilitating the informed consent process
Providing the patient a point of contact for all clinical trial questions or concerns. Being available and present in clinic and in the Chemotherapy Treatment Unit when the patient is dosed
Meeting the patient in clinic for all visits during treatment and follow up to ensure the patient is fully informed and any questions or concerns addressed. Being available in the clinic to the physician and the patient to ensure protocol compliance and source data is documented appropriately and according to Good Clinical Practice. Attending clinic at the time of the patient visit to ensure all adverse event documentation and concomitant medication information is documented according to the protocol requirements. Ensuring all patient protocol appointments are scheduled as required
JOB DUTIES & RESPONSIBLITIES:
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. Complete sand submits to the CRIS Office and/or JHS CTO Office 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.
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.
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.
Execute 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 the following: 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.
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. Other duties as assigned.
Core Requirements: Bachelor's degree and one year of relevant clinical experience.