Clinical Research Associate Internship
il y a 2 semaines
**CRA Internship - Office Based Paris**
**IQVIA Offers fantastic opportunity for students who wish to become a CRA.**
By joining IQVIA as CRA Intern you will engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
**This is a Full Time, 6 Months Internship Contract, office based in IQVIA office in Paris.**
**Essential Functions**
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Gain experience in study procedures by working with experienced clinical staff.
- Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
- Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- Under close supervision, 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 enrolment, Case Report Form (CRF) completion and submission, and data query generation and resolution.
- Under close supervision, 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.
- Under close supervision may support start-up phase.
- Under close supervision, 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 in scientific discipline or health care preferred.
- Prior clinical experience preferred.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- 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 co-workers, managers and clients.
- Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
**Driver’s License
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