Clinical Research Associate - IQVIA BIOTECH (homebased in France)

Due to our continued growth we are recruiting for a Sr. Clinical Research Associates to join our team. This is a great opportunity for a CRA to join a progressive and developing CRO.

IQVIA Biotech is unique division specialising in working with smaller biotech and emerging biopharma clients and as such we have a vibrant fastpaced working environment.

Responsibilities

Perform site monitoring visits (selection initiation monitoring and closeout 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 startup 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 followup 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 within either Life Science Nursing Pharmacy or a medical degree
Previous experience as a Study Coordinator
Minimum of 1 year of experience in Monitoring on Site visits one or more therapy areas ideally oncology
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 problemsolving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers managers and clients.

IQVIA 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