Full Time Clinical Research Protocol Writer Jobs

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

The MACS/WIHS Combined Cohort Study (MWCCS) seeks a full-time Clinical Research Coordinator 1 to implement clinical research protocols, ensure participant retention, and conduct baselines, follow-ups and core assessments. Under Dr. Deborah Jones' supervision, the role involves meticulous adherence to protocols and assessment tasks. Strong interpersonal skills, motivation, and professionalism are essential. Comprehensive training on research protocols will be provided, with potential involvement in screening and baseline assessments. This role is ideal for those passionate about community engagement and research, especially within LGBTQ and HIV/AIDS-affected populations.

Core Job Functions

• 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

• Assists with study visits, screening, scheduling participants, assessments, and measurement activities per the study protocol.
• Conducts screening, interviews, and baseline assessments at various locations, including UM/Jackson HIV Clinic, Converge and CRB.
• Maintains and updates records, codes data for electronic processing, and retrieves data electronically.
• Performs clerical duties including typing, answering phone calls, and maintaining study binders.
• Coordinates appointments and study visit schedules, preparing correspondence and handling phone inquiries.
• Monitors and reports adverse events, ensuring participant advocacy and adherence to quality standards.
• Develops networking opportunities within academic and community circles to enhance collaborative recruitment efforts.
• Maintains confidentiality and adheres to university standards when handling participant information and data.
• Attends and participates in meetings, conferences, and training groups as requested, staying current with required skills and training.
• Performs inventory of supplies, prepares kits as needed, and adheres to university policies and procedures, safeguarding University assets.
• Perform any additional duties as assigned.

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 1 year of relevant experience
• 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.

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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