Clinical Trial Assistant

Johnson & Johnson; São Paulo; Teletrabalho; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

A leading company in healthcare innovation is seeking a Clinical Trial Assistant to support the Local Trial Manager and Site Manager in managing clinical trials. This role involves ensuring compliance with regulations, providing logistical support, and maintaining trial documentation. Ideal candidates will have a degree in Life Sciences or Nursing and relevant clinical trial experience, along with strong organizational and interpersonal skills.

Qualificações

• Minimum of a BA or BS degree in Life Sciences, Nursing or related field required.
• 2+ years relevant clinical trial experience preferred.
• Proficient in English and strong knowledge of MS Office.

Responsabilidades

• Provide administrative and logistical support to LTM and/or SM.
• Ensure trial-related activities comply with GCO SOPs and local regulations.
• Maintain and update trial documents and information systems.

Conhecimentos

Interpersonal skills

Negotiating skills

Organizational skills

Formação académica

BA or BS degree in Life Sciences, Nursing or related field

Ferramentas

MS Office

Descrição da oferta de emprego

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

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

São Paulo, Brazil

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at: https://www.jnj.com/innovative-medicine

We are searching for the best talents for this 1 position of Clinical Trial Assistant (home based).

Purpose:

The Clinical Trial Assistant supports the Local Trial Manager (LTM) and/or Site Manager (SM) to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials. Ensures trial related activities are compliant with GCO SOPs, policies and local regulatory requirements. May contribute to process improvement, training and mentoring of other CTAs.

Principal Responsibilities:

1. Provide administrative and logistical support to LTM and/or SM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies and local regulatory requirements.
2. Support the local study team in performing site feasibility and/or country feasibility.
3. Maintain information in relevant systems.
4. Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.
5. Support LTM and/or SM in collecting/preparing documents required for study startup/submission to IEC/IRB and/or HA.
6. Support LTM and/or SM in collecting, processing and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.
7. May assist LTM in conducting local investigator meetings or with making arrangements for the investigators participating in an international meeting.
8. Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution.
9. Comply with all training requirements.
10. Ensure inspection readiness at all times.
11. May contribute to process improvement including, but not limited, to representing functional area in process initiatives and contribute to optimization of daily processes.
12. May be assigned as a coach and mentor to a less experienced CTA.

Education and Experience Requirements:

• A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
• Skills set corresponding with 2+ years relevant clinical trial experience is preferred; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
• Proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint). Strong interpersonal and negotiating skills preferred. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.