Clinical Research Coordinator 2 (A)

University of Miami; Miami (FL); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Tuition remission

Job summary

The University of Miami is seeking a Clinical Research Coordinator 2 to support planning, coordinating, implementing, monitoring, and evaluating clinical studies. You will assist in day-to-day protocol operations, ensure participant safety, and maintain regulatory compliance across multiple trials.

The role liaises with study teams, sponsors, and staff to facilitate smooth study progress. Responsibilities include recruitment activities, performing study procedures, specimen handling, data entry

Qualifications

• Bachelor’s degree in a relevant field is required.
• Minimum 2 years of relevant experience is required.
• Ability to learn procedures, adapt to changing priorities, and work in a team.

Responsibilities

• Assist in participant recruitment and screening for eligibility.
• Perform study procedures, data collection and daily operations for moderate risk protocols.
• Collect, process, pack and ship specimens per protocol and guidelines.
• Maintain study binders and files; support IP handling and accountability.
• Monitor adverse events and protocol deviations; assist with amendments under PI supervision.
• Coordinate startup and ongoing operations including SIVs, monitoring visits, and audits.

Skills

Learning Agility

Teamwork

Technical Proficiency

Communication

Education

Bachelor’s degree in relevant field

Job description

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 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. 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. 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 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.

Department Specific Job Functions

Supports recruitment, prescreening, and enrollment of participants across pulmonary, critical care, and sleep medicine clinical trials, including studies involving COPD, asthma, ILD, bronchiectasis, and sleep disorders. Coordinates and performs study visits and procedures in accordance with protocol requirements, including pulmonary function testing coordination (PFTs), six-minute walk tests, biospecimen collection, and patient-reported outcome assessments. Oversees collection, processing, storage, and shipment of biological specimens (blood, sputum, etc.) following sponsor protocols, IATA guidelines, and institutional policies. Maintains accurate and audit-ready regulatory binders and study files in accordance with UM, sponsor, and FDA/ICH-GCP requirements. Supports investigational product (IP) handling and accountability (when applicable), including coordination with IDS/pharmacy and ensuring proper documentation per protocol. Monitors, documents, and reports adverse events (AEs/SAEs), protocol deviations, and unanticipated problems, ensuring timely reporting to sponsors, IRB, and regulatory bodies. Implements protocol amendments, including updating study documents, revising workflows, and reconsenting participants as needed under PI supervision. Coordinates study startup and ongoing operations, including assisting with site initiation visits (SIVs), monitoring visits, and audit readiness activities. Tracks study progress, enrollment, and data entry timelines; ensures investigators are regularly updated and milestones are met across multiple active protocols. Serves as a point of contact for sponsors, CROs, monitors, and internal collaborators; supports effective communication and issue resolution across cross-functional teams. Performs timely and accurate data entry into EDC systems (e.g., Medidata, REDCap), resolves data queries, and ensures source documentation is complete and consistent. Collaborates with clinical teams (physicians, RTs, nurses) to coordinate protocol-required procedures during routine patient care and research visits. Ensures compliance with all applicable regulatory requirements, including FDA, ICH-GCP, HIPAA, and institutional policies governing human subjects research.

Certification and Licensing

Phlebotomy

Benefits

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

Job Status

Full time Employee Type: Staff

Equal Opportunity Employer

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

About the University

The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.