Job Description
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The University of Miami/UHealth Department of OBGYN 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.
- 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.
DEPARTMENT SPECIFIC JOB FUNCTIONS - Reviews and administers informed consent forms to study participants.
- Schedules patients for research-related visits and contacts patients for clinical follow-up requirements.
- Coordinates activities between departments to accomplish study goals.
- Assists investigators in study related tasks, follow-up visits, procedures, and assessments as required per protocol
- Maintains updated records of long-term follow-up participants, collect and required data on a timely manner respond to sponsor queries Retains records of payments to study participants.
- Completes patients' data forms and reviews medical charts for patients' vital signs and other medical data to complete case report forms.
- Complete and manage regulatory binder documents according to protocol and institutional requirement
- Complete study related activities such as device management, device insertion and removal.
- Maintains records of study results and study participants. Keeps an active pool of study candidates to ensure availability.
- Coordinates the implementation of multiple complex clinical research protocols.
- Develops SOPs and templates with guidance from the PI/Clinical Research Nurse Manager.
- Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.
- Manages and performs sample collection, 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
- Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.
- Organizes/manages site visits and internal/external auditing activities as assigned.
- Coordinates research team meetings; assures communications across-the-board.
- 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
- Bachelor's degree in relevant field required
- Minimum 2 years of relevant experience required
- Refer to department description for applicable certification requirements
- 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.
This is a core job profile description and is not reflective of all duties that may be assigned to a specific position in each individual department. The above statements are intended to describe the general nature and primary responsibilities of this core job profile. Specific duties and tasks may vary based upon departmental needs. Other duties may be assigned to the above consistent with the knowledge, skills, and abilities required for the job.
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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
Job Tags
Full time, Temporary work, Work at office, Local area, Worldwide