Clinical Research Coordinator 2

University of Miami•Miami, FL

3d•Onsite

About The Position

The University of Miami/UHealth Department of Pediatrics- Infectious Disease has an exciting opportunity for a full time Clinical Research Coordinator 2 to work in Miami, FL. 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.

Requirements

Bachelor’s degree in relevant field required
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.

Nice To Haves

Any appropriate combination of relevant education, experience, and/or certifications will be considered.
Ability to work with children and their caregivers.
Bilingual English and Spanish/Creole speakers are highly preferred, because of the high volume of patients we have who are Spanish or Haitian creole speakers.
Willingness to work with down syndrome pediatrics patients.
Ability to work in several studies at the same time.

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.
Assist principal investigators, project managers in coordinating Federal and/or industry-sponsored research studies.
Prepare annual continuing review reports and modifications and submit to the different IRBs; update/train study staff; maintain regulatory binders.
Responsible for the coordination of the research meetings and attendance of the study-specific calls.
Evaluate and monitors timelines for studies and for each subject participant to comply with applicable protocols.
Assure data is complete and submitted on time.
Verify the accuracy of research data and performs quality assurance/control checks.
Responsible for the proper collection, processing, and handling of specimens as required by the study protocol.
Assist in the preparation and submission of monthly invoices to the sponsor.
Serve as a backup coordinator for the multiple studies run at the department.