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Manager Clinical Trials Operations (Full Time, Day Shift)

RI - CLINICAL TRIAL OPERATIONS Florida-Miami-Nicklaus Children's Hospital - Main Hospital Campus Miami, Florida Requisition ID 24027

Description

Job Summary

Manages the Clinical Trials Unit team who serve Nicklaus Children's Health System community of investigators in partnership with the Director of Research. Oversees the Clinical Research Coordinators (CRC), Data Assistants, and CRC Leads in the department including all CTU-related metrics (screenings, enrollments, workload/bandwidth, productivity, and hiring).          

Job Specific Duties

  • Works with the Director and other stakeholders to support the research mission of NCHS. 
  • Assist Director in the development and evaluation of goals and objectives that align with the NCHS strategic imperatives and manages the activities to support the implementation of such objectives. 
  • Manages the Clinical Trials Unit and staff to include monitoring staff attendance, productivity, and performance markers. Responsible for providing and/or overseeing staff related activities including orienting, ongoing coaching/training, and performance evaluations. 
  • Works with the Research Operations Manager and Study Start-Up personnel to evaluate the feasibility of new clinical research studies for successful enrollment at NCHS, including assessment of available patient population, timeline for enrollment, and availability of resources to meet the protocol requirements. 
  • Ensures Research Institute Clinical Trial Management System (CTMS) is accurate, up-to-date, and reviewed in accordance with management plans, specifically the study status, research participant enrollment status, and study personnel are accurate and up-to-date.
  • Serves as a liaison with investigators, sponsor representatives, and other external entities to facilitate understanding of the Human Research Protection Program (HRPP) and foster compliance with research regulations and policies. 
  • Generate and provide accurate and contemporaneous study portfolio and enrollment metrics/reports to leadership and departments/service lines.
  • Oversees business development activities for the Clinical Trials Unit and establishes rapport with outside vendors, such as sponsors and CROs, to maintain present business and to generate new business while safeguarding the protection of research participants. 
  • Schedules and participates in re-occurring huddles and meetings with Clinical Trials Unit staff to relay important information to the staff and  serve as an open forum for staff feedback and general discussion. 
  • Ensures all necessary training is available and provided to the Clinical Trials Unit to maintain AAHRPP accreditation.  
  • Identify barriers to quality services, compliance, or ineffective processes as it related to the clinical trials unit staff and their functions. 
  • Responsible for CTU employee hiring, promotions, disciplinary actions, and termination in partnership with the Director. 

Qualifications

Minimum Job Requirements

  • Bachelor's Degree in Biomedical or Business Management 
  • Clinical Research Certification (CCRC, CCRP, or CCRA) via SOCRA or ACRP
  • 4-7 years of clinical research supervisory/management experience in either an academic hospital engaged in research, university, Clinical Research Organization, or Pharmaceutical/Medical Device company

Knowledge, Skills, and Abilities

  • Experience in pediatric clinical research preferred.
  • Knowledge of federal regulations governing research.
  • Knowledge of the types of clinical research.
  • Leadership qualities including problem solving skills.
  • Able to relate cooperatively and constructively with clients and co-workers.
  • Effectively monitor and develop the abilities of subordinates.
  • Possesses strong attention to detail and follow-up skills.
  • Ability to communicate effectively both verbally and in writing.
  • Ability to use logical thinking to interpret research study protocols and solve a broad range of problems.
  • Ability to use analytical skills and provide productivity assessments.
  • Ability to interpret, adapt, and react calmly under stressful conditions.
  • Able to maintain confidentiality of sensitive information.


Job :

Management

Primary Location :

Florida-Miami-Nicklaus Children's Hospital - Main Hospital Campus

Department :

RI - CLINICAL TRIAL OPERATIONS-2100-380863

Job Status


:Full Time
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Joining a new organization can be daunting or overwhelming. But at Nicklaus, your colleagues make you feel welcomed. They taught me to celebrate our accomplishments and band together during challenging times. This is not easy to find in healthcare these days, so I’m grateful to have found an amazing place to work with people and leadership who have my well-being in mind.

Lova Renee Brunson Manager Accreditation & Regulatory

Collaboration leads to success.

Alone we can do so little; together we can do so much. Working together, we find solutions and methods we would never find alone, and at Nicklaus Children’s, we have fun doing it.

Responsibility drives us.

We all take responsibility here – for the children, their families, our work and each other. We meet our responsibilities head on and motivate each other to succeed.

Empower yourself, help others.

Nicklaus Children’s encourages team members to believe in their ability to affect positive change in the world through everything they do with us.

Advocate for the right way.

Advocate for children. Advocate for families. Advocate for yourself. But most of all, advocate for getting the job done right and you will find nothing but success and support in your career here.

Transformation is growth.

At Nicklaus Children’s, change is not to be feared. When you work here, you are always working with the most advanced tools and procedures available.

Empathy is everything.

We expect our team members to have empathy for the patients and families they treat, and in turn, we have empathy for them. We take care of everyone in the Nicklaus Children’s family with competitive benefits and our supportive culture.

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As champions for children, Nicklaus Children’s is committed to putting the health and safety of our patients, families, medical staff and employees first. With the increasing number of adults and children in our community experiencing illness from the coronavirus and its variants, our course of action is clear. Vaccination offers proven protection against severe COVID-19-related illness. All members of our team are required to be fully vaccinated against COVID-19. Accommodations are being made for those who have a medical reason where they cannot receive the vaccine or have a strongly held religious basis for not obtaining it.

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