Clinical Research Coordinator 2

University of Miami•Miami, FL

About The Position

The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work at the UHealth Medical Campus. 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. The Clinical Research Coordinator 2 is a mid-level professional working within the Neurology Stroke Division. This role involves assisting in the planning, coordination, implementation, monitoring, and evaluation of specific clinical research studies. The coordinator supports daily operations related to the execution of clinical research protocols, from initiation to close-out, ensuring compliance with regulatory and sponsor guidelines. Responsibilities include collaborating with study team members, faculty, and other staff or study sites to maintain participant safety and adherence to approved protocols. Duties covered in this position encompass all aspects of clinical trial coordination, emphasizing regulatory compliance and participant safety. In addition, the Clinical Research Coordinator-2 must work closely with and maintain constant communication with the Study Principal Investigator and Senior Study Coordinators to ensure alignment and seamless execution of research activities. The coordinator also manages administrative tasks, facilitates information flow, and organizes study activities and personnel. Duties covered in this position encompass all aspects of clinical trial coordination, emphasizing regulatory compliance and participant safety. The Clinical Research Coordinator 2 is responsible for coordinating clinical research trials within the Neurology Stroke Division, including the following functions: Complete and maintain the institution-required training essential to gain certification in research ethics, compliance, and regulatory standards to conduct human subject studies. Completion of all study-specific trainings and certifications. Support multiple stroke research studies by performing various duties. Assist with the startup of new studies. Assist in onboarding and training new study team members. Provide guidance and oversight to junior research coordinators. Perform quality assurance (QA) on study binders in preparation for study monitor visits. Communicate with Research Pharmacy/Investigational Pharmacy to ensure proper management and accountability of study medication Demonstrate the ability to work independently or collaboratively within a team environment. Ability to work independently and/or in a collaborative environment. Ability to work in a fast-paced environment due to the limited time window for enrollment in acute Stroke clinical trials. Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations. Prepares local and Central IRB submissions including initial submission, continuing reviews, reportable events, and amendments. 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.

Requirements

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.
Flexible hours may be necessary depending on clinic days.
Ability to work independently and/or in a collaborative environment.
Ability to work in a fast-paced environment due to the limited time window for enrollment in acute Stroke clinical trials.

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.
Screening participants for eligibility.
Conducting the informed consent process.
Enrolling participants and, as required, performing randomization according to the study protocol.
Coordinate the follow up study visits following the protocol.
Ensuring regulatory compliance throughout the study.
Maintain study files according to protocol requirements, UM guidelines, and department policy.
Entering study data into the electronic database in a timely manner.
Assisting with investigational medication dispensing from the Research Pharmacy/Investigational Pharmacy.
Communicate with the Research Pharmacy/Investigational Pharmacy to ensure the study medication is kept following the study specifications and maintain accurate study drug accountability.
Monitors compliance with processing, storing and shipping participant specimens to central research laboratory as per the study protocol.
Meeting with study monitors and maintaining all regulatory documents.
Assist in onboarding and training new study team members.
Provide guidance and oversight to junior research coordinators.
Perform quality assurance (QA) on study binders in preparation for study monitor visits.
Prepares local and Central IRB submissions including initial submission, continuing reviews, reportable events, and amendments.