Clinical Research Coordinator 3

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The department of Psychiatry has an exciting opportunity for a Clinical Research Coordinator 3 to work onsite on the UHealth campus. 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.

CORE FUNCTIONS

• 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.

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
• 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

Knowledge, Skills and Attitudes:

• 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.
• Oversee the management of specific research requirements within the department. This includes coordinating with principal investigators and regulatory bodies to ensure smooth protocol implementation, participant recruitment, and data collection.
• Implement quality assurance measures to ensure the integrity and reliability of research data within the department. This could involve developing standardized procedures, conducting regular audits or reviews, and implementing corrective actions as needed.
• Assist in the development and review of research protocols within the department. This could involve providing input on study design, feasibility assessments, and protocol revisions to ensure scientific rigor and compliance with regulatory standards.
• Oversee data management and analysis activities for research projects within the department. This could include developing data collection tools, ensuring data quality and completeness, and collaborating with biostatisticians or data analysts for data analysis.
• Assist in grant proposal development and budget management for research projects within the department. This could involve preparing grant applications, tracking project expenditures, and ensuring compliance with funding agency requirements.

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 time

Employee Type:

Staff

Pay Grade:

A10