University of Miami
Clinical Research Coordinator 3
University of Miami, Miami, Florida, us, 33222
Clinical Research Coordinator 3
The Sylvester Comprehensive Cancer Center has a great opportunity for a Clinical Research Coordinator 3. The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies’ daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study’s integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.Responsibilities:
Coordinates the implementation of multiple complex clinical research protocols.Develops SOPs and templates with guidance from the PI/Clinical Research Manager.Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.Manages sample 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/scientific manuals.Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.Provides leadership in identifying and working through ethical conflicts arising during protocol implementation, and refers these conflicts to the Research Ethics Team for consults as needed.Organizes/manages site visits and internal/external auditing activities as assigned.Coordinates research team meetings; assures communications across-the-board.Assures synchronization of study visits/procedures/clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.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.MINIMUM QUALIFICATIONS:Bachelor’s degree in relevant field required.Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months.Minimum 4 years of relevant experience required.Skill in collecting, organizing and analyzing data.Ability to recognize, analyze, and solve a variety of problems.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.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.Patient safety is a top priority. As a result, during the Influenza 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 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.
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The Sylvester Comprehensive Cancer Center has a great opportunity for a Clinical Research Coordinator 3. The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies’ daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study’s integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.Responsibilities:
Coordinates the implementation of multiple complex clinical research protocols.Develops SOPs and templates with guidance from the PI/Clinical Research Manager.Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.Manages sample 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/scientific manuals.Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.Provides leadership in identifying and working through ethical conflicts arising during protocol implementation, and refers these conflicts to the Research Ethics Team for consults as needed.Organizes/manages site visits and internal/external auditing activities as assigned.Coordinates research team meetings; assures communications across-the-board.Assures synchronization of study visits/procedures/clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.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.MINIMUM QUALIFICATIONS:Bachelor’s degree in relevant field required.Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months.Minimum 4 years of relevant experience required.Skill in collecting, organizing and analyzing data.Ability to recognize, analyze, and solve a variety of problems.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.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.Patient safety is a top priority. As a result, during the Influenza 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 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.
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