Clinical Research Coordinator 2 (Genitourinary -GU)

University of Miami; Miami (FL); Presencial; USD 65.000 - 85.000; Jornada completa

Descripción de la vacante

The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Clinical Research Coordinator 2 to work at UHealth in Miami, Florida. This role supports planning, coordinating, and evaluating clinical studies, ensuring participant safety and protocol adherence.

You will work closely with study teams to manage day-to-day operations and regulatory compliance. Responsibilities include recruitment assistance, data collection, specimen handling, document management, and

Formación

• Bachelor's degree in a relevant field is required.
• 2+ years of relevant experience preferred.
• Demonstrated learning agility and ability to work in a team environment.
• Strong written and verbal communication skills.

Responsabilidades

• Assist in participant recruitment and screening for eligibility.
• Perform study procedures, data collection, and daily operations of moderate risk protocols.
• Collect, process, package, and ship specimens per protocol.
• Maintain study binders and filings per protocol requirements.
• Distribute study materials as delegated by the PI.
• Monitor and report adverse events and protocol deviations.
• Assist with protocol amendments and study orientations.
• Support communications with sponsor teams, data centers, and collaborators.

Conocimientos

Learning Agility

Teamwork

Technical Proficiency

Communication

Educación

Bachelor's degree in relevant field

Descripción del empleo

The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Clinical Research Coordinator 2 to work at UHealth in Miami, Florida.

CORE JOB SUMMARY

The Clinical Research Coordinator 2 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 JOB FUNCTIONS

• 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.
• Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
• Assists with study orientation and protocol related in-services to research team and clinical staff.
• Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
• Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators' academic administrative personnel, and departments.
• Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
• Adheres to cultural competency guidelines; implements strategies to meet study participants' needs for language translation, health literacy, etc.
• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
• 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.

CORE QUALIFICATIONS

Education: Bachelor's degree in relevant field required

Experience: Minimum 2 years 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.

This is a core job profile description and is not reflective of all duties that may be assigned to a specific position in each individual department. The above statements are intended to describe the general nature and primary responsibilities of this core job profile. Specific duties and tasks may vary based upon departmental needs. Other duties may be assigned to the above consistent with the knowledge, skills, and abilities required for the job.

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 m