Clinical Research Coordinator 3

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The University of Miami / UHealth Department of SCCC CRS has an exciting opportunity for a Full Time Clinical Research Coordinator 3 to work at the UHealth campus in Miami, Fl.

CORE JOB SUMMARY

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 JOB FUNCTIONS

1. Coordinates the implementation of multiple complex clinical research protocols.

2. Develops SOPs and templates with guidance from the PI / Clinical Research Manager.

3. Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.

4. Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.

5. Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive / corrective actions.

6. Develops, disseminates, and assures adherence to study-related clinical research best practices / scientific manuals.

7. Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.

8. 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.

9. Organizes / manages site visits and internal / external auditing activities as assigned.

10. Coordinates research team meetings; assures communications across-the-board.

11. Assures synchronization of study visits / procedures / clinical tests with data collection schedules, established timepoints; manages progress of study participants through protocol; expedites overall study progression.

12. Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.

13. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.

14. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.

15. 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

Education : Bachelor's degree in relevant field required

Experience : Minimum 4 years of relevant experience required

Certification and Licensing : Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months. If you do have the certification, you will have 6 months to obtain it.

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

Department Specifics :

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.

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 - 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