Clinical Research Coordinator 2

If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.

The Department of Otolaryngology is currently seeking a full time Clinical Research Coordinator 2 to work in Miami, FL. The Clinical Research Coordinator 2 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. Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
2. Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
3. Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
4. Maintains study binders and filings according to protocol requirements, UM and department policy.
5. Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
6. Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
7. Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
8. Assists with study orientation and protocol related in-services to research team and clinical staff.
9. Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
10. Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators' academic administrative personnel, and departments.
11. Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
12. Adheres to cultural competency guidelines; implements strategies to meet study participants' needs for language translation, health literacy, etc.
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

Certification and Licensing:

Not Applicable

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 University's core values.
• Ability to work independently and/or in a collaborative environment.

DEPARTMENT ADDENDUM

Department Specific Functions

Purpose:

Clinical and outcomes research, coordination with translational and social science research; management of complex research data collection infrastructure; coordination and organization for clinical research involving patients with chronic and serious illness.

Position dimensions include:

Interfacing across departments; working with research subjects; data infrastructure management; helping with the development of research publications; contributing to grant applications; involvement with sponsored studies, training and supervision of research assistants and trainees.

Working Environmental Conditions:

Working on a collaborative research team with the PI, research assistants, and collaborators; liaison with informational technology and electronic medical record personnel; direct subject contact for consents and longitudinal follow-up, focus groups; videoconferencing meetings and in-person meetings.

The majority of work will be on the main UM medical campus with occasional travel to satellite clinics. May require intermittent evening or after hours commitments.

Department Specific Qualifications

Education:

Minimum education: experience in Medicine, Health Services, Public Health, or related fields. Graduate education encouraged.

Advanced Spanish Language and English fluency required.

Certification and Licensing:

Must have or obtain compliance with all Research certifications, including Good Clinical Practice and Blood borne pathogens.

Appropriate certifications and training in consenting patients, clinical research ethics, and regulatory research management

Experience:

3 or more years of minimum work experience in: Direct patient research, including consenting, quantitative methodological skills, database management, and experience with clinical research regulatory compliance.

Capacity to independently run day-to-day operations for complex research studies. Experience working with patients.

Knowledge, Skills and Attitudes:

• Contributes to clinical and applied research activities including data collection, consenting patients, longitudinal patient follow-up, subject tracking, maintaining regulatory compliance, IRB submissions and modifications, and authors technical and agency reports.
• Collaborates with the PI and senior staff on the development of research publications.
• Creates and conducts clinical research and basic descriptive analysis of the results.
• Manages clinical databases
• Run day-to-day operations for large complex research studies, including PI-driven research, grant-funded research, and sponsored studies
• Assists the PI and senior staff in preparing materials for submission to granting agencies and foundations.
• Provides ready access to all experimental data for senior staff and research team
• Requests or acquires equipment and supplies for assigned project(s).
• Uses the Internet, surveys, databases, electronic medical record, and other available sources to collect research information.
• Interfaces across departments with research collaborators, and funding agencies.
• Participation in new skill development
• Assist with qualitative research
• 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.

#ED-LI1

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:

Employee Type:

Pay Grade: