Clinical Research Coordinator 1

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The University of Miami/UHealth Department of Pediatrics has an exciting opportunity for a full time Clinical Research Coordinator 1 to work in Miami, FL.

The Clinical Research Coordinator 1 serves as an entry-level clinical research professional that has a foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. The incumbent is responsible for simple clinical research protocols and timelines.

Core responsibilities:

• Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
• Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules 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, including those 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.

Department Specific Functions:

• Coordinate the collection, processing and delivery of specimen samples to designated lab.
• Responsible for the timely reporting of adverse events to the IRB.
• Provide administrative assistants to main researchers (PI's).
• Coordinate the receipt, distribution and administration of trials drugs.
• Request, replenish and closeout petty funds.
• Maintain study binders for each protocol according to study requirements.
• Maintain study drug accountability and study drug distribution with help of research pharmacy.
• Responsible for complex research protocols and timelines of research studies up to 4 years.
• Report adverse events and unanticipated events per each protocol to appropriate advisory committees and oversees the follow-up regarding each adverse event.
• Identify protocol deviation, alerting the sponsor to current or potential protocol deviations, documents each protocol deviation, and foresees the correction of such deviations.
• Perform research tests, experiments, and sample processing for each protocol including but not limited to: EKG, serum isolation, plasma isolation, PWV, and cognitive testing.
• Process, pack, and ship specimens according to each protocol and shipping regulations.
• Recruit and enroll patients into each research protocols.
• Complete informed consent process with the future participants and explain the details of each protocol and what it entails.
• Coordinates research visits and scheduling with the patient and the physician, plan study timelines to meet rigorous demands of the study and lead monthly meetings pertaining to project evaluation of each study.
• Handle petty cash and clincard registering for participant payment and reimbursement.
• Review medical records to help in determining patient eligibility.
• Involved in data collection and uploading data into the Electronic Data Capture (EDC) system and resolving queries in the EDC.
• Responsible for responding to sponsors and CRO on behalf of the PI and directly involved in site monitoring visits with CRA. Those responsibilities include scheduling the meeting with the CRA, overseeing the visit and aiding in source verifying the information.

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.

Core Qualifications:

• Bachelor's degree in relevant field required
• Minimum 1 year of relevant experience required
• Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
• Teamwork: Ability to work collaboratively with others and contribute to a team environment.
• Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
• Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

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