Clinical Research Coordinator 2

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The Hussman Institute has an exciting opportunity for a Clinical Research Coordinator 2 position. The incumbent serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation, and carries out study coordination duties from protocol initiation to study close-out 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 study-related administrative tasks, facilitate across-the-board 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 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.

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 required

• Minimum 2 years of relevant experience

Department Specific Functions

This position will focus on our genetic studies of Hispanics in Alzheimer disease.

The primary function of this job is to identify, recruit, and enroll Hispanic American individuals and families in the community of South Florida that would be eligible for our Alzheimer disease project. Once enrolled, the job requires the collection of biological samples and relevant clinical data from multiple sources depending on the study protocol. This will require travel to multiple areas in both the US as well as possibly the Caribbean and South America. In addition to these activities, this job requires organization of and participation in community outreach activities to increase awareness of and interest in genetic research among underserved populations.

Fluent in English and Spanish is preferred.

The Clinical Research Coordinator is a member of the Section of Family and Patient Ascertainment within the Center for Genomic the John P. Hussmann Institute for Human Genomics.

Job Description

*Support multiple genetics research studies by performing a variety of duties involved in the collection, compilation, documentation and analysis of clinical and genetic research data from study participants. This position will focus on our genetic studies of Alzheimer disease in Hispanic American communities.

*Organize, host, participate in community education, and outreach activities to recruit populations historically underrepresented in genetics research.  Outreach events may include extended consecutive periods of participant ascertainment

*Identify, recruit, and enroll families for our genetic studies of Alzheimer disease in all Hispanic American individuals.

*Schedule and enroll participants. This will require careful management of calendars and coordination with other staff.

*Coordinate and manage enrollment activities for respective studies. This will entail setting up local and remote trips that will involve travel (including overnight travel, driving and air travel). This may require travel to participants in their homes or to medical clinics/hospitals.

*Collect biological samples per study protocols. This will most frequently involve drawing blood or collecting saliva from participants.   

*Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation.

*Enter clinical data and identify new strategies to maximize efficiency of data entry. Assist in preparation of clinical data reports and analyses; recommend new methods for collection and documentation of data; write and revise procedural manuals as required. Use data management and analysis software, including programs for drawing human pedigrees, basic statistical software and query-based extraction of clinical and laboratory data from relational database.

*Function as a member of a multidisciplinary research team.

*Prepare ascertainment reports for presentation to the investigative team.

*Organize and manage the flow of information to and from participants and families; maintain contact information for families and participants; develop efficient strategies for following up with families on a regular basis.

*Participate in regular clinical meetings and staff training sessions.

*Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients’ progress to include documentation and reporting of adverse events; recommend corrective actions as appropriate.

*Perform other related duties incidental to the work described herein.

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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. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status:

Full time

Employee Type:

Staff