Clinical Research Associate, Multi-Sponsor, Belgium

IQVIA; Zaventem; Sur place; EUR 40 000 - 55 000; Plein temps

Avantages offerts par ce poste

Career growth resources

Flexible work schedules

Excellent working environment

Company car

Mobile phone

Attractive benefits packaging

Résumé du poste

IQVIA Belgium is seeking a Clinical Research Associate to perform monitoring and site management, ensuring compliance with study protocols. The role involves conducting site visits, recruiting subjects, and maintaining communication with study sites.

The ideal candidate holds a relevant degree and has at least 2 years of CRA experience. Strong organizational skills and fluency in Dutch, French, and English are essential. The position offers opportunities for career growth and an attractive benefits package, including a company car.

Qualifications

• 2+ years of experience as a Clinical Research Associate.
• Ability to establish and maintain effective working relationships.
• Driver’s license class B is required.

Responsabilités

• Perform site monitoring visits as per protocol and regulatory requirements.
• Manage progress of assigned studies and ensure proper conduct at sites.
• Evaluate site practices and report quality issues as appropriate.

Connaissances

Computer skills (MS Office)

Excellent command of Dutch

Excellent command of French

Excellent command of English

Organizational skills

Time management skills

Problem-solving skills

Flexibility to travel

Formation

University degree in scientific discipline or health care

Description du poste

Clinical Research Associate

IQVIA Belgium is looking for talented and motivated experienced CRA to join our Site Management team. At this position you will have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas, and build a meaningful, strong career within our organization.

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 and guidelines, and sponsor requirements.

Your Responsibilities Will Include

• Perform site monitoring visits (selection, initiation, monitoring and close-out 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 start-up phase.
• 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 GCP and local regulatory requirements.
• 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.
• 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.

Your Profile

• University degree in scientific discipline or health care
• 2+ years of experience as a CRA
• Very good computer skills including MS Office
• Excellent command of Dutch, French and English language. Belgium based.
• Organizational, time management and problem-solving skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients
• Flexibility to travel
• Driver’s license class B

What You Can Expect

• Resources that promote your career growth
• Leaders that support flexible work schedules
• Programs to help you build your therapeutic knowledge
• Excellent working environment in a stabile, international, reputable company
• Company car, mobile phone and attractive benefits packaging