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Clinical Trials Research Coordinator - (Full Time, Day Shift)

RI - CLINICAL TRIAL OPERATIONS Florida-Miami-Nicklaus Children's Hospital - Main Hospital Campus Miami, Florida Requisition ID 24345
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Description

Job Summary

Coordinates clinical research studies on human subjects. Responsible for subject recruitment (screening, consenting support and enrollment), follow-up, data management (entry and reporting), detailed record keeping, regulatory compliance, report writing, and correspondence with investigators, IRBs, sponsors, CRO's and regulatory authorities. Responsible for new research application (including study start-up processes and requirements) and submission of protocols with subsequent amendments. Participates in protocol writing as needed and maintains initial and continuing education for Good Clinical Practice compliance.

Job Specific Duties
  • Attends and participates in investigator meetings, pre-study visits, and initiation meetings or coordinator meetings as appropriate.
  • Collects and maintains accurate patient data for submission to Sponsor, maintaining proper patient records, coordinating the collection, and shipments of specimens as required by protocol. 
  • Communicates study objectives/procedures to relevant hospital units involved with the study including the establishment of good rapport with the Principal Investigator & providing required assistance. 
  • Communicates with the Sponsor or their representatives, schedules and facilitates study monitor visits, and facilitates communication between Principal Investigator and Sponsor or Sponsor’s Representatives.
  • Complies with the Research Finance Compliance policies and procedures including reporting requirements to research finance staff. 
  • Interacts with patients and families to recruit (screen, consent and enroll) study subjects and ensures compliance with the protocol. 
  • Responsible for speedy and adequate patient enrollment as determined by Research Management and Principal Investigator in all assigned studies.
  • Submits new protocols to Research Regulatory Affairs team (for IRB submission/approval) and verifies proper document were received with the proper format. 
  • Submits amendments of protocols to Research Regulatory Affairs team and verifies the required corrections were inserted following the established procedures.
  • Utilizes Good Clinical Practices in the conduct of clinical trials as per established protocol. 
  • Follows NCHS RI’s Standard Operating Procedures, AAHRPP, HIPAA and FDA guidelines for clinical research, and keeps updated in those procedures and/or guidelines. 
  • Enters Research Patient information into CTMS within 72hours of enrollment, patient visit or patient-related event. 
  • Provides new Protocols, Amendments and study status updates to necessary research staff for digitization/entry into CTMS. 

 

Qualifications

Minimum Job Requirements

  •  AA/medical/technical school or 2 years of research and/or healthcare experience required

Knowledge, Skills, and Abilities

  • AA or medical/technical school preferred.
  • Experience in pediatric clinical research in a hospital setting preferred.
  • Bilingual in English/Spanish preferred.
  • Clinical research certification (CCRC, CCRP, CRA) and IATA certification preferred.
  • Excellent communication skills in working with both children and adults.
  • Excellent organizational skills, detail-oriented, people-oriented, flexible, and adaptable to change.
  • Excellent time management skills.
  • Knowledge of protocols and its process.
  • Software applications experience including word processing, scheduling and contact database, email, web browsing, hospital records, other database software and office equipment.
  • Experience with relevant hospital equipment for each clinical trial project.



Job :

Research

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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