Clinical Research Associate - Sponsor dedicated

IQVIA; Paris; Sur place; EUR 40 000 - 70 000; Plein temps

Résumé du poste

An established industry player is seeking a dedicated Site Manager to oversee clinical trials and ensure compliance with regulatory standards. In this dynamic role, you will perform site monitoring visits, manage recruitment plans, and maintain documentation to support ongoing projects. Your expertise in clinical research, along with strong organizational and communication skills, will be essential in fostering effective relationships with study teams and sites. Join a forward-thinking company that values innovation and strives to make a significant impact in healthcare through advanced analytics and technology solutions.

Qualifications

• 2+ years of onsite monitoring experience in clinical research.
• Strong knowledge of GCP and ICH guidelines.

Responsabilités

• Conduct site monitoring visits and manage study progress.
• Evaluate quality and integrity of study site practices.

Connaissances

Onsite Monitoring Experience

Communication Skills

Organizational Skills

Problem-Solving Skills

Time Management

Financial Management

Knowledge of GCP and ICH Guidelines

Proficiency in Microsoft Office

Formation

High School Diploma

Degree in Scientific Discipline or Healthcare

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

iPhone

iPad

Description du poste

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations, guidelines, and sponsor requirements.

Essential Functions

1. Perform site monitoring visits (selection, initiation, monitoring, and closeout visits) in accordance with the contracted scope of work and Good Clinical Practice.
2. Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.
3. Administer protocol and related study training to assigned sites and establish regular communication to manage ongoing project expectations and issues.
4. Evaluate the quality and integrity of study site practices related to proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
5. 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 resolution. Support startup phase if applicable.
6. Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator Site File (ISF) is maintained according to GCP and local regulatory requirements.
7. Create and maintain documentation regarding site management and monitoring visit findings, including submitting regular visit reports, follow-up letters, and other required documentation.
8. Collaborate and liaise with study team members for project support as appropriate.
9. If applicable, support development of project subject recruitment plans on a per-site basis.
10. If applicable, manage site finances according to the clinical trial agreement and retrieve invoices as required.

Qualifications

• High School Diploma or equivalent; Degree in scientific discipline or healthcare preferred.
• Requires at least 2 years of onsite monitoring experience.
• Equivalent combination of education, training, and experience may be accepted in lieu of degree.
• Good knowledge of and skill in applying applicable clinical research regulatory requirements (GCP, ICH guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Proficiency in Microsoft Word, Excel, PowerPoint, and familiarity with using a laptop, iPhone, and iPad (if applicable).
• Strong written and verbal communication skills, including good command of English.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

At IQVIA, we believe in pushing the boundaries of human science and data science to make a significant impact in creating a healthier world. Our advanced analytics, technology solutions, and contract research services are supported by 70,000 employees worldwide who apply their insight, curiosity, and courage every day. Learn more at [website].

Required Experience and Key Skills include expertise in CSS, Cloud Computing, Health Education, Actuary, and Building Electrician.