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At Alpha Bioresearch we know that the company's greatest asset is people, which is why we care about fostering their professional and personal development by offering the possibility of internal promotion as well as work flexibility. We are in constant search of the best professionals, people prepared with the desire to take over the world. Do you want to be part of this great little family?
Alpha Bioresearch's recruitments are financed by the European Social Fund.
Available Job Offers
Responsible for the regulatory activities of start-up, monitoring and closure of the assigned Alpha Bioresearch studies. Meeting the required quality parameters.
Gather information on the requirements to obtain IRB / EC approvals, and subsequent follow-up documentation and provide updates to the Regulatory portal.
Be the contact person for the project centers regarding the collection of essential documents and manage the presentations of Ethics Committees and Regulatory Agencies.
Processing of contracts between the Promoter of a research project and the center and / or foundation.
Creation and maintenance of project files: study master file (Trial Master File) and investigator site file.
Management of the shipment of project material.
REQUIREMENTS
At least 1 YEAR as a CTA in a CRO or in the pharmaceutical industry.
Great teamwork skills
Great ability to communicate and interact with other teams.
Knowledge of the ICH-GCP guidelines and local and international legislation on clinical research.
Knowledge of Computer Science at the user level: Word, Excel, Outlook, PowerPoint, Internet Explorer.
High level of spoken and written English (assessable Portuguese).
TERMS
Immediate incorporation.
REMUNERATION: According to experience
Responsible for the centers / researchers of the assigned studies until their closure.
Act as an intermediary between the promoter of a research, the researcher and the institutions
Good relationship with the research centers to guarantee that they comply with the established times.
Collaborate in the preparation and attendance at a meeting of researchers.
Planning and conducting all types of visits (viability, selection, monitoring and closure) in accordance with the monitoring plan.
Management of the shipment of project materials.
Detect and ensure the correct management of adverse events and adverse reactions occurring in patients within a research project.
Guarantee the integrity of the data and keep all the records, documents and material of the assigned research projects updated.
REQUIREMENTS
At least 1 YEAR as a CRA in center management, including monitoring visits in a CRO or in the pharmaceutical industry.
Higher bachelor's degree in health sciences or similar.
Master in clinical research or equivalent experience.
Great teamwork skills
Great ability to communicate and interact with other teams.
Knowledge of the ICH-GCP guidelines and local and international legislation on clinical research.
High level of spoken and written English (assessable Portuguese).
TERMS
Immediate incorporation.
REMUNERATION: According to experience
Responsible for the global management of the project from the beginning to the closing of the database and closing activities, complying with the required quality parameters.
It acts as a point of contact with the promoter of the assigned projects.
Responsible for the quality and compliance with the assigned protocols.
Manage the project team.
Manage the project budget.
Organize and ensure the specific training of the team involved in the project.
Functionally manage the team involved in the project.
Communication with the promoter.
Act as a backup for the CRA or other team personnel.
Carry out monitoring and co-monitoring visits to the research centers.
You will be able to perform all CRA functions and tasks both in projects in which you are listed as a CPL, as well as in other projects.
REQUIREMENTS
At least 5 years developing CRA functions in CRO or pharmaceutical industry.
Project management training.
Great teamwork skills.
Great ability to communicate and interact with other teams.
Knowledge of the ICH-GCP guidelines and local and international legislation on clinical research.
Knowledge of Computer Science at the user level: Word, Excel, Outlook, PowerPoint, Internet Explorer.
High level of spoken and written English (assessable Portuguese).
TERMS
Immediate incorporation.
REMUNERATION: According to experience
Its main function is to prepare, review and process the activities of statistical exploitation of the data generated in the research projects, ensuring the veracity, consistency and reliability of the same, as well as the rigor of the results.
Specifically, the functions of the biostatistician are:
Production of analyzes and graphs from data from clinical studies.
Contribute to the preparation of analysis plans.
Prepare, document and test the required programs and the procedure for data inclusion in clinical / statistical reports or other similar reports.
Prepare outputs for the integrated process of clinical trials.
Perform quality control procedure on clinical data.
Prepare the sample size calculation and the statistical analysis section of the clinical study protocols.
As a data manager, you will perform the following functions:
Review and process project data to ensure the accuracy and consistency of the study database.
Occasionally it can act as a data recorder.
REQUIREMENTS
University degree or higher degree preferably in statistics, mathematics.
Knowledge of ICH / GCP and legislation applicable to clinical research.
Knowledge of data management and statistical applications.
High knowledge of computer tools.
Intermediate level of English.
Methodological aspects of clinical research.
TERMS
Immediate incorporation
REMUNERATION: According to experience