Clinical Research Associate, Multi-Sponsor

IQVIA; France; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

An established industry player is seeking dedicated individuals to join their structured training program for clinical monitoring. This role involves gaining hands-on experience in conducting clinical visits while adhering to protocols and regulations. You will work closely with experienced clinical staff, develop essential skills, and contribute to the integrity of clinical research. Join a leading global provider of clinical research services, where your efforts will help accelerate the development of innovative medical treatments and improve patient outcomes worldwide. If you are passionate about healthcare and eager to make a difference, this opportunity is for you.

Qualifications

• Bachelor's degree in a scientific discipline or healthcare is preferred.
• Prior clinical experience is preferred, with some organizations requiring 2 years.

Responsabilités

• Conduct site monitoring visits under close supervision and ensure compliance with protocols.
• Evaluate study site practices and escalate quality issues as necessary.

Connaissances

Written and verbal communication skills

Organizational skills

Problem-solving skills

Time management skills

Financial management skills

Formation

Bachelor's Degree in scientific discipline or health care

Equivalent combination of education, training and experience

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Laptop computer

iPhone

iPad

Description du poste

Job Overview
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.

Essential Functions

1. Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
2. Gain experience in study procedures by working with experienced clinical staff.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. Under close supervision may support start-up phase.
9. 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.
10. Collaborate and liaise with study team members for project execution support as appropriate.
11. If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.

Qualifications

1. Bachelor's Degree in scientific discipline or health care preferred.
2. Equivalent combination of education, training and experience may be accepted in lieu of degree.
3. Prior clinical experience preferred.
4. Some organizations may require 2 years of clinical experience.
5. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
6. Written and verbal communication skills including good command of English language.
7. Organizational and problem-solving skills.
8. Effective time and financial management skills.
9. Ability to establish and maintain effective working relationships with coworkers, managers and clients.
10. Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
11. Knowledge of applicable protocol requirements as provided in company training.

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 https://jobs.iqvia.com