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The Department of Clinical Translational Research Site has an exciting opportunity for a Full Time Clinical Research Coordinator 2. 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.
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 Education:
- Provides professional level support for research studies. Implements research protocol and monitors participant adherence to protocol.
- Establishes patient/participant screening procedures.
- Determines data to be collected and develops forms for collections/summarizing data.
- Establishes and maintains contact with patient/participants, health care providers, community agencies, study sponsors.
- Provides professional level support for research studies and assists in the design of studies.
- Develops, verifies and implements procedures to accomplish research goals.
- Implements research protocol and monitors participant adherence to protocol.
- Verifies accuracy of research data and monitors data quality control.
- Works together with the Regulatory Specialist to ensure compliance.
- Establishes patient/participant screening procedures with Principal Investigator and obtains relevant medical information from patient clinic charts/medical records.
- Maintains logs/progress reports to track both currently enrolled as well as follow-up patients/participants.
- Maintains drug accountability records for study drugs.
- Determines data to be collected and develops forms for collecting/summarizing data.
- Maintains and assists clinical research computer database and enters data onto case reports and/or into database as appropriate.
- Ensures data integrity and consistency in computer database and written records.
- Completes corrections/queries required at audits/monitor visits and takes action to correct deviations as needed.
- Establishes/maintains contact with patient/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 staff and patients/participants about research protocols.
- 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.
Bachelor's degree in relevant field required.Certification and Licensing:
Clinical Research Certification, preferred.Experience:
Minimum Two (2) years of relevant experience. Three (3) years of relevant work experience in clinical trials management or research experience in clinical trial setting, preferred.Knowledge, Skills and Attitudes:
Any appropriate combination of relevant education, experience and/or certifications may be considered.#LN-AL1
- 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.
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.
Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.
The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.Job Status:
Full timeEmployee Type:
This job has expired.