Job Overview

Conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

Essential Functions

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties.

• Work with experienced clinical staff.

• Perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.

• Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.

• Ensure 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.

• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) /  International Conference on Harmonization (ICH) and local regulatory requirements.

• May support start-up phase.

• 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.

Qualifications

• 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.

• Prior 2 years clinical oncology experience mandatory.

• 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.

• Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Knowledge of applicable protocol requirements as provided in company training.

• Be flexible with the ability to travel nationwide

• Flexible working hours in an hybrid or home-based role in Paris, Lyon, Marseille