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University of Miami · 2 weeks ago

Clinical Research Coordinator 2 - Full Time - Bascom Palmer Eye Institute, Miami

Miami, FL

Full-time

Onsite

Entry, Mid Level

2+ years exp

The University of Miami's Bascom Palmer Eye Institute is seeking a Clinical Research Coordinator 2. This role involves planning, coordinating, implementing, monitoring, and evaluating clinical research studies while ensuring participant safety and adherence to protocols.

Higher Education

H1B Sponsor Likely

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 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

Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records

Ability to handle multiple clinical trials with several principal investigators

Serves as back up study coordinator to other clinical trials

Obtains informed consent from patients/study participants and documents the process in alignment with policies and procedures

Recruits patients referred by physicians, schedules study appointments, prepares for and conducts study visits in the clinic

Processes and ships participant biological samples to central labs according to safety regulations

Collaborates with the research pharmacy to dispense study medication and maintain unmasked study records

Completes corrections/queries required at audits/monitor visits and takes action to correct deviations, as needed

Establishes/maintains contact with patients/participants, health care providers, community agencies, and study sponsors

Updates appropriate agencies (such as sponsors, IRB, etc.) regarding current status of research project

Provides in-service education to study team members about research protocols

Enters data into electronic data capture system within specified timelines and meets sponsor’s data lock deadlines

Maintains study regulatory files, including delegation of authority logs, training records, and sponsor correspondence

Maintains participant files, including informed consent forms, source documents, and participant compensation/reimbursement records

Prepares and submits annual continuing reviews to the Institutional Review Board (IRB)

Notifies IRB of protocol amendments, safety reports, and reportable information in compliance with applicable regulations

Implements research protocols and monitors participant and study team adherence

Invoices sponsor and performs study account reconciliation with the research administration team

Travels to sponsored Investigator Meetings out of state, as needed

Flexibility to travel to all Bascom Palmer Eye Institute sites, as needed

Qualification

Clinical research coordinationInformed consent processData collectionRecordingRegulatory compliancePatient recruitmentPrioritizeAttention to detailConfidential information handlingCollaborative work

Required

Bachelor's degree in relevant field

Minimum 2 Years Of Relevant Experience

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

Ability to handle multiple clinical trials with several principal investigators

Obtains informed consent from patients/study participants and documents the process in alignment with policies and procedures

Processes and ships participant biological samples to central labs according to safety regulations

Completes corrections/queries required at audits/monitor visits and takes action to correct deviations, as needed

Updates appropriate agencies (such as sponsors, IRB, etc.) regarding current status of research project

Enters data into electronic data capture system within specified timelines and meets sponsor's data lock deadlines

Maintains study regulatory files, including delegation of authority logs, training records, and sponsor correspondence

Maintains participant files, including informed consent forms, source documents, and participant compensation/reimbursement records

Prepares and submits annual continuing reviews to the Institutional Review Board (IRB)

Notifies IRB of protocol amendments, safety reports, and reportable information in compliance with applicable regulations

Implements research protocols and monitors participant and study team adherence

Invoices sponsor and performs study account reconciliation with the research administration team

Flexibility to travel to all Bascom Palmer Eye Institute sites, as needed

Benefits

Medical

Dental

Tuition remission

And more

Company

University of Miami

Glassdoor3.9

At UM you'll join a diverse and energized academic community.

Founded in 1925

Coral Gables, fl, US

5001-10000 employees

http://miami.edu

H1B Sponsorship

University of Miami has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (208)

2024 (151)

2023 (149)

2022 (121)

2021 (95)

2020 (114)