Vaga monitor de pesquisa clínica PCD

Essential Functions
* Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
* Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
* Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
* Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
* Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
* Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigators Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
* Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
* Collaborate and liaise with study team members for project execution support as appropriate.
* If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
* If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications
* Bachelors Degree Degree in scientific discipline or health care preferred. Req
* Equivalent combination of education, training and experience may be accepted in lieu of degree.
* Some organizations require completion of CRA training program or prior monitoring experience.
* Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
* Good therapeutic and protocol knowledge as provided in company training.
* Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
* Written and verbal communication skills including good command of English language.
* Organizational and problem-solving skills.
* Effective time and financial management skills.
* Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

IQVIA é líder global no uso de informação, tecnologia, análises avançadas e expertise humana para ajudar seus clientes a impulsionar a área da saúde. Juntamente com as empresas com as quais trabalhamos, estamos possibilitando um sistema de saúde mais moderno, efetivo e eficiente, desenvolvendo soluções inovadoras que transformam os resultados para os negócios e os benefícios para os pacientes.

A combinar

Vale Refeição, Vale Alimentação, Vale Transporte, Plano de Saúde, Plano Odontológico,

Outros
Gympass, Bonus Anual

Graduação Cursando.

Inglês - Avançado;

Sim. Para as cidades de: Sao Paulo

Cidades: Sao Paulo

1 vaga para PCD.

Sim.

Não informado.

Candidato PCD, lembre-se de atualizar seu currículo com o número do CID e com um breve descritivo de sua deficiência para facilitar o recrutamento e seleção.