Clinical Trial Coordinator II
Date de publication :
13 septembre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :East
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Johnson & Johnson MedTech, is recruiting for a Clinical Trial Coordinator II, located anywhere in East coast or Midwest in United States.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.
At Johnson & Johnson, we all belong.
Job Description:
The Clinical Trial Coordinator (CTC II) supports the planning and coordination in all aspects of clinical trial operations. This position requires a thorough understanding of clinical trials, including how to support a trial from site feasibility/qualification to site activation. A CTC II will work closely with the clinical project team to collect all essential regulatory documents for a clinical study (at both study and site level) in a timely fashion and store appropriately while ensuring compliance with ICH/GCP guidelines, federal regulations, and corporate policies and procedures. The position involves interaction with internal and external customers and partners, and must operate with a high degree of discretion, as the role involves handling information of a confidential and critical nature.
Primary Duties and Responsibilities:
- Support the management of trial-related systems such as the electronic Trial Master File (eTMF), including set up, maintenance and study close out.
- Assures collection of essential clinical trial documents (i.e., CVs, Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements) from investigational sites for efficient study start-up/site activation.
- Support site start-up activities including reviewing study specific ICF templates, managing and communicating the status of sites and study’s start-up progress.
- Plan, coordinate, and arrange study communications on and off-site with both internal and external partners.
- Responsible for supporting the drafting of meeting agendas and detailed meeting minutes.
- Maintain quality of collected regulatory documents, which include a precise QC process and proper review in accordance with Good Documentation Practices (GDP) when documents are received.
- Communicate with investigator sites on collection of regulatory documents, Institutional Review Board submissions and other trial-related information.
- Collaborate with multifunctional teams to resolve issues on collected essential documents as required per assigned studies.
- Maintain accuracy of clinical trial registration information.
- Provide assistance with communication and coordination for trial committee interactions, as needed.
- Provide support during audits and inspections, as applicable.
- Create, populate, review, approve, distribute, and track study materials as assigned by the Clinical Project Manager and Clinical Program Manager.
- Accountable for accurate organization and maintenance of filing systems and tracking departmental documentation.
- Regularly interact with high-level internal and external clients to coordinate the accomplishment of business needs.
- Support efforts for and/or prepare a variety of correspondence and complex PowerPoint presentations.
- Ability to perform additional responsibilities as requested.