Clinical Research Coordinator 3

University of Miami; Miami (FL); On-site; USD 70,000 - 95,000; Full time

Job summary

The University of Miami/UHealth Department of SCCC is seeking a Full Time Clinical Research Coordinator 3 at the UHealth campus in Miami, FL. The role leads planning, implementation, monitoring, and evaluation of multiple clinical research protocols, mentors junior coordinators, and ensures study integrity and participant safety.

Responsibilities include coordinating complex protocols, developing SOPs, overseeing recruitment and sample handling, and ensuring compliance with regulatory standards

Qualifications

• Bachelor’s degree in a relevant field is required.
• Certification in Clinical Research (ACRP or SoCRA) or the ability to obtain within six months is required.
• Minimum 4 years of relevant clinical research experience.
• Strong data collection, analysis and problem-solving abilities.
• Ability to manage multiple activities under deadlines while maintaining confidentiality and working independently or with a team.

Responsibilities

• Coordinate implementation of multiple complex clinical research protocols.
• Develop SOPs and templates with guidance from PI/CR Manager.
• Oversee eligibility screening and recruitment; implement accrual strategies.
• Manage sample processing, packing and shipping per protocol and regulations.
• Plan and monitor deviations, incident reporting and corrective actions.
• Disseminate information and ensure regulatory/ethics compliance across sites.

Skills

Data collection

Problem solving

Time management

Confidential information handling

Independent / collaborative work

Education

Bachelor’s degree in relevant field

Certification in Clinical Research (ACRP or SoCRA) or ability to obtain within 6 months

Job description

The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 3 to work at the UHealth campus in Miami, Fl.

CORE JOB SUMMARY

The Clinical Research Coordinator 3 (A) serves as experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies’ daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study’s integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.

CORE JOB FUNCTIONS

• Coordinates the implementation of multiple complex clinical research protocols.
• Develops SOPs and templates with guidance from the PI/Clinical Research Manager.
• Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.
• Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.
• Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations.
• Develops and implements preventive/corrective actions. Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.
• Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
• Provides leadership in identifying and working through ethical conflicts arising during protocol implementation and refers these conflicts to the Research Ethics Team for consults as needed.
• Organizes/manages site visits and internal/external auditing activities as assigned. Coordinates research team meetings; assures communications across-the-board. Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression. Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders. 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

Certification and Licensing:

Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months OR you will have six months to obtain the certification.

Experience:

Minimum 4 years of relevant experience

Knowledge, Skills and Attitudes:

• Skill in collecting, organizing and analyzing data.
• Ability to recognize, analyze, and solve a variety of problems.
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
• Ability to process and handle confidential information with discretion.
• 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. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status:

Full time

Employee Type:

Staff