Clinical Research Coordinator 2
University of Miami

Job Info

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Clinical Research Coordinator 2

The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work at the UHealth Medical Campus.

Core Summary

The Clinical Research Coordinator 2 (A) serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel.

Core Responsibilities

• Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.

• Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.

• Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.

• Maintains study binders and filings according to protocol requirements, UM and department policy.

• Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.

• Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.

Department Specific Functions

• Prepare, submit, and track protocol applications, amendments, annual reviews, and sponsor communications to the Institutional Review Board (IRB), ensuring all documentation complies with regulatory requirements.

• Collect, analyze, and ensure the quality of study data by performing routine quality assurance checks, while maintaining compliance with study protocols and regulatory standards.

• Provide regular updates to the Principal Investigator (PI) on enrollment metrics, financial status, and overall study performance to ensure alignment with research objectives.

• Conduct budget preparation and feasibility assessments for new studies, leveraging prior budget templates and collaborating with senior Clinical Research Coordinators and the Office of Research Assistance.

• Supervise and mentor research assistants in maintaining an up-to-date participant database, ensuring that accurate information is available weekly and promptly accessible to the PI.

• Oversee successful communication with potential study participants by supervising outreach efforts, utilizing various communication methods (phone, email, text, MyChart) to ensure timely engagement and recruitment.

• Identify and assess potential candidates for clinical studies by reviewing patient medical charts and data sources, collaborating closely with the PI and clinical teams, and maintaining effective communication channels through shared calendars.

• Ensure proper maintenance of source documents in patient binders according to good documentation practices (ALCOAC standards), meeting regularly with auditors to verify compliance, and minimizing protocol deviations or violations.

• Review and understand study protocols prior to meetings with the PI and Office of Research Assistance, ensuring thorough preparation and adherence to study guidelines.

• Implement innovative strategies to identify and advertise clinical studies to eligible patients, such as targeting specific patient populations and coordinating with department resources for recruitment optimization.

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

• Minimum 2 years of relevant experience

Knowledge, Skills and Attitudes:

• 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.

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 - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:Full timeEmployee Type:StaffPay Grade:A9

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