Detalhe da Oferta:
Overview
As a Clinical Trial Assistant (CTA)/Project Manager (PM), you will be joining an innovative Research Technology Organisation in the health area dedicated to the development and clinical research of new products for medical therapy and diagnostic imaging.
On this CTA/ PM role, you will be supporting the team of PM and Clinical Research Associate (CRA) to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials.
You will ensure trial related activities are in compliance with Good Clinical Practice (GCP) Standard Operating Procedures (SOPs), policies and local regulatory requirements.
Responsibilities
What you will be doing:
• Partner with the PM and CRA to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
• Development of study documents.
• Support the local study team in performing site feasibility and/or country feasibility.
• Where applicable, work with investigational site staff and local CRA to ensure accurate/complete regulatory documents are in place to expedite Ethics Committee (EC) or Health Authority (HA) (if applicable) approval process.
• Support the PM or, where applicable the CRA, in providing the current and complete documents requested by the EC and HA.
• Maintain site level protocol information in Trial Management Systems (e.g. CMS).
• Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.
• Support the CRA/PM in collecting and maintaining all documents throughout the trial and post-trial in both eMaster File and paper files.
• Track payments to clinical sites and vendors.
• Distribute, collect, review, and track regulatory documents, agreements and training documentation.
Qualifications
• Degree in Health Sciences or Management
• Proficient in English language and Portuguese native
• Strong knowledge with MS Office (e.g. Outlook, Word, Excel, and PowerPoint)
• Strong interpersonal and negotiating skills
• Excellent organizational skills and the ability to collaborate and handle multiple priorities
• Perform activities in a timely and accurate manner.
• Preferentially, relevant clinical trial experience or equivalent.
Knowledge, Skills and Abilities
• Good knowledge of project management skills and processes
• Knowledge of applicable policies and procedures, SPOs, work instructions and other guidance documents
• Excellent spoken and written communication skills; excellent presentation skills
• Strong interpersonal, collaboration and time management skills
• Ability to establish and maintain effective working relationships with project team and client
Conditions
• Workplace: AIBILI, Coimbra
• Full-time
The successful candidate will be offered for a working contract, according to its training and experience.
AIBILI is an inclusive, equal opportunity employer.
Applications must be submitted at AIBILI web site:
https://nextcloud.aibili.pt/candidaturas/index.php?formID=D4vF3sCEGm