Clinical Research Associate - reputed company BIOTECH (homebased in Paris)

At reputed company Biotech, we partner with visionary biotech companies to transform innovation into patent impact. With dedicated teams, deep therapeutic expertise, and a biotech tailored model, we accelerate clinical development from early phase through global registrational studies. The successful candidate must be based in a commutable distance to Paris.

Responsibilities

• reputed company site monitoring visits (selection, initiation, monitoring and reputed company-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 reputed company study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and reputed company of study site practices reputed company to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. • Manage the reputed company of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query reputed company 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 Investigator's 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

 Background reputed company either Life Science, Nursing, Pharmacy or a medical degree • Previous experience as a Study Coordinator • Minimum of 1 year of experience in Monitoring on Ste visits one or more therapy areas, ideally oncology • Bachelor's 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 reputed company 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 reputed company Word, reputed company 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.

reputed company is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.reputed company.com

reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.