Level III - Clinical Research Coordinator
UHealth at Plantation
Plantation, FL
5x8 hrs, Days

The SCCC department is seeking a Clinical Research Coordinator 3 that will assist the Principal Investigator in the conduct all aspects of the clinical trial, under the direct supervision of the Principal Investigator, and Clinical Research Manager. The CRPM provides support to the research team in the management of multiple research protocols to assure compliance per FDA, WHO, UM, and CRS regulations and policies. The CRPM will be mentored by senior level research coordinators to take on research responsibilities of increasing complexity.

JOB DUTIES & RESPONSIBLITIES:

Assists the Monitors and research coordinators in the organization and preparation of Site Initiation Visits (SIV) and in providing research support to patients and their families.
Attends site disease group tumor board meetings and site disease group collaborative meetings.

Works with coordinators to ensure that all eligibility source documents are complete and eligibility checklists are complete.

Execute the plan developed for collection of protocol specific subject specimens, i.e. pharmacokinetics samples, blood specimen, tissue samples, etc. as per protocol. Works closely with research coordinators and nursing staff to ensure that specimens are collected as required.

Provides oversight to completing the protocol preparedness and start-up process for all trials within assigned site disease group.

Takes the lead for research study kit management and works closely with the research lab to ensure proper management of specimen orders.

Assists in maintaining /logs progress reports to track both currently enrolled as well as follow-up participants.

Mentors' data coordinator in entering data onto case report forms and/or into computer database. Completing corrections/queries required at audits/monitor visits in a timely manner. Ensuring data integrity and consistency in computer database and written records by reviewing entered data for accuracy.

Monitors adherence to protocol. Takes action to report and correct deviations or other problems. Assisting with entering RNIs into IRB 7

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.

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.

Assists Principal Investigator with physical exams, vital signs, and placing orders for exams.

Other duties as assigned.

Minimum Qualifications (Essential Requirements):
BS degree in science, health care, or related field
A minimum of 4 years effective work-related experience in clinical settings, hospitals, or research, etc. is required. High-level interpersonal skills are required. Excellent English oral and written communication skills and strong computer skills are required.
A Research Coordinator Certification by the ACRP is required. If the certification is not obtained at time of hire, the incumbent will have six months from the time of hire to obtain the certification.
Knowledge of medical terminology.
Ability to manage multiple tasks simultaneously.
Attention to detail & accuracy.
Applicant must be willing to obtain a research related certification within 2 years of employment