Clinical Research Coordinator 2 - Research - Full Time Bascom Palmer Miami FL
Clinical Research Coordinator 2 - Research - Full Time Bascom Palmer Miami FL
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Job Description
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The University of Miami Bascom Palmer Eye Institute Department of Research is seeking a full time Clinical Research Coordinator 2 in Miami Florida.
The Clinical Research Coordinator 2 (A) serves as a midlevel clinical research professional that assists in the planning coordinating implementing monitoring and evaluating of specific clinical research studies. This role assists in the daytoday operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study closeout 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 studyrelated administrative tasks facilitate acrosstheboard flow of information and coordinate study activities and personnel.
CORE JOB FUNCTIONS
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 followsup 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 inservices 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 unitlevel policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be allinclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
Education:
Bachelors degree in relevant field
Experience:
Minimum 2 years of relevant experience
Knowledge Skills and Attitudes:
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 Universitys core values.
Ability to work independently and/or in a collaborative environment.
DEPARTMENT ADDENDUM
Department Specific Functions
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 inservice education to study team members about research protocols.
Enters data into electronic data capture system within specified timelines and meets sponsors 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.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical dental tuition remission and more.
UHealthUniversity of Miami Health System South Floridas only universitybased health system provides leadingedge 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 subspecialties 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. Were the challenge youve been looking for.
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:
StaffPay Grade:
A9Required Experience:
IC
Employment Type
Full-Time
