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.

• 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.