Clinical Research Coordinator 1

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The University of Miami/UHealth Department of Public Health has an exciting opportunity for a full time Clinical Research Coordinator 1 to work in Miami, FL.

The Clinical Research Coordinator 1 will primarily work coordinating a study funded by the American Cancer Society and a multi-site study funded by the National Cancer Institute. The goal of the study funded by the American Cancer Society is to develop and test a cognitive behavioral intervention (Acceptance and Commitment Therapy) to improve emotional wellbeing among Spanish-speaking Latina women living with metastatic breast cancer. The goal of the study funded by the National Cancer Institute is to prospectively characterize treatment side effects/toxicities and quality of life among 416 diverse individuals with metastatic cancer who are starting an immune checkpoint inhibitor (a form of immunotherapy).

Core responsibilities:

• Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.
• Maintains enrollment procedures according to the protocol.
• Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
• Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
• Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
• Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
• Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
• Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
• Knows the contents and maintenance of study-specific clinical research regulatory binders.
• 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.

Department specific functions:

• Contribute to applied research activities by recruiting, collecting and analyzing data, maintaining databases, etc.
• Understand and interpret research protocols and procedures for the project
• Assist with developing, maintaining, and implementing standard operating procedures for the project
• Carry out research activities in accordance with research protocols
• Assist/coordinate day-to-day and large-scale study management
• Assist/coordinate meetings among research team (internal and external) and prepare agenda for meetings
• Assist with study start-up/preparing research materials (i.e., data collection instruments/study documents)
• Assist with REDCap setup and managing REDCap data
• Assist with coordinating and scheduling on-site visits with organizations
• Assist with (and in some cases lead) on-site data collection: field observation notes/jottings, formal and informal interviews, reviewing strategy workflows/SOPs
• Assist with data collection debriefs with PI and delegate of PI
• Assist with qualitative data analyses and data integration (directed by PI and delegate of PI)
• Assist with and conduct literature reviews
• Coordinate and facilitate interviews and focus groups
• Assist/coordinate recruitment efforts for implementers and organizations
• Assist with ACS and NIH progress reports and UM sponsored award reports
• Collaborate with PI, collaborators, and other staff to publish findings in refereed journals
• Complete weekly individual meetings with supervisor and prepare detailed agendas for meetings (as needed)
• Lead or supervise extraction of clinical data from the EHR/EMR
• Advance knowledge related to job duties through continued education, training and/or research, as assigned by supervisor

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. Master’s degree in relevant field is desirable but not required.
• Minimum 1 year of relevant experience required. Previous experience working with oncology patients and recruiting in clinical care settings is preferred.
• Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates is optional.
• Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
• Teamwork: Ability to work collaboratively with others and contribute to a team environment.
• Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
• Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
• Spanish-English bilingualism is required.
• Ability to conduct assignments research activities methodically with attention to detail.
• Strong interpersonal and professional skills.
• Basic knowledge about cancer and cancer therapies.
• Excellent communication – verbal and written, interpersonal and organizational skills, and a collaborative management style.
• Ability to effectively communicate and interact with physicians and other clinical staff.
• Ability to engage in critical thinking and anticipate facilitators and barriers to progress.
• Spirit of flexibility and commitment to collaboratively work with PI and other team members to meet project goals.
• Skilled in collecting, organizing, and analyzing complex data (qualitative and quantitative).
• Basic skills in use of SPSS or comparable statistical program.
• Able to be self-directed in developing study materials, while also being open to feedback and modification.
• Strong motivation to conduct research with rigor and integrity.

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.

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