Entry Level Clinical Research Protocol Writer Jobs

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The Clinical Translational Research Site is currently seeking a full time Clinical Research Coordinator 1 to work in Miami.

The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.

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.

CORE QUALIFICATIONS:

Education:

Bachelor's degree in relevant field

Experience:

Minimum 1 year 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 Specific Functions

1. Assists with participant recruitment and retention activities and screens potential study participants for eligibility.
2. Collects, processes, and ships specimens in accordance with protocol and regulations.
3. Maintains study binders and files in accordance with protocol requirements, UM, and department policy.
4. Distributes study drug materials in accordance with practice standards and clinical credentials, as delegated by the Principal Investigator.
5. Assists in implementing protocol amendments under the direct supervision of the Principal Investigator.
6. Assists with study orientation and protocol-related in-services for the research team and clinical staff.
7. Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; and submits progress reports according to the established schedule.
8. Learns the research team and assists with communications and interactions with sponsors, data coordinating centers, compliance monitors, collaborators, investigators' academic and administrative personnel, and departments.
9. Assists with administrative tasks for study personnel, including orientation, documenting core competencies, certification mandates, safety and responsible conduct of research education, and performance reviews.
10. Adheres to cultural competency guidelines and implements strategies to meet study participants' needs for language translation, health literacy, etc.
11. Follows the fundamental requirements of all international, national, and local regulatory bodies.
12. Local travel may be required.

Department Specific Qualifications

Experience:

Bilingual in English and Spanish is preferred but not required.

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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