Sr. Clinical Research Associate (Netherlands)

Alimentiv; Amsterdam; On-site; EUR 65,000 - 85,000; Full time

Job summary

Alimentiv is seeking an experienced Senior CRA to independently perform, coordinate, and oversee all aspects of clinical site monitoring services in line with ICH-GCP and sponsor SOPs. The role acts as the primary liaison with investigative sites and mentors CRA I & II while ensuring protocol adherence and regulatory compliance.

Travel is required (up to 40-60%), with home-based work options. The candidate should have 4–9 years of related experience, a Bachelor's (Honors) degree, and Fluent

Qualifications

• 4 - 6 years of related experience.
• 7 – 9 years of related experience.
• Bachelor’s degree (Honors) required.
• Master’s degree preferred.
• Fluent in written and verbal English.

Responsibilities

• Independently conduct and document onsite and remote site monitoring and close-out visits.
• Review data for consistency with source documents and study requirements.
• Resolve data queries and escalate issues as appropriate.
• Coordinate shipment of clinical supplies and study documents.
• Ensure site staff are trained on protocol, study plans, ICH-GCP.
• Participate in progress meetings and Investigator’s meetings.
• Review ISF/TMF for accuracy, timeliness, and completeness; request documents as required.
• Act as primary contact for investigational sites and oversee study integrity.
• Support site access to study systems and ensure training compliance.
• Address site-related issues to resolution and manage deviations.
• Coordinate project-wide communications to provide ongoing data and updates.
• Identify and advise on site investigator selection and activation.
• Support start-up by following up on pending documents; translate site documents as required.
• Assist regulatory localization and translation of site documents.
• Help optimize patient recruitment and meet milestones.
• Mentor CRA I & II; participate in CRA interviews.
• Participate in process improvement initiatives and best practices.
• Perform CRA Assessment Visits and co-monitoring visits.

Skills

Communication

Organizational skills

Problem-solving

Attention to detail

Driver's license

Education

Bachelor's degree

Master's degree

Tools

Medidata Rave

Oracle InForm

IRT

eTMF

CTMS

Microsoft Office

Job description

Independently performs, coordinates and oversees all aspects of the clinical site monitoring services, assessing protocol and regulatory compliance as per Alimentiv’s and sponsor’s standard processes, ICH/GCP guidelines and local regulation. Serves as the primary liaison between the sponsor/Alimentiv and investigative sites by playing a critical role in the execution of clinical study plans. Provides guidance and mentoring CRA I and II, collaborating effectively with cross-functional stakeholders in a dynamic, results-driven and high-accountability environment. Perform CRA Assessment Visits and participate in audits/inspections, when required.

Site Monitoring activities (55-60%)

• Independently conduct and document onsite and remote activities, including site monitoring and close-out visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance
• Collaborate with site staff to review and ensure that the data reported in the applicable study system(s) is consistent with the source documents and compliant with study requirements
• Monitor, resolve and/or facilitate resolution of data queries and escalated issues as appropriate
• Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents
• Ensures site staff is trained in all aspects of the study including but not limited to the protocol, study plans, systems and ICH-GCP
• Participate in routine study progress meetings, teleconferences, and Investigator’s meetings
• Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required

Site Management activities (15-20%)

• Act as a primary contact for any questions or issues that arise from investigational sites
• Oversee overall integrity of the study and promote positive working relationships with the site staff and study team members
• Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements
• Ensure all site related issues are followed until resolution, including action items and protocol deviations
• Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle
• Regularly review the study related systems remotely to ensure compliance, accuracy and completeness
• Translate site documents for TMF filing when applicable
• Routinely review the TMF for accuracy, timeliness, and completeness. Request documents from the site, as required
• Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents
• Participate in audits/inspections and follow-up on issues and implement actions, when required
• Participate in routine study progress meetings and teleconferences

Site Recruitment and Setup (15-20%)

• Identify and advise on site investigators selection, independently conduct and document onsite and remote activities, including site qualification and initiation visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance
• Coordinate the shipment and delivery of clinical supplies, including but not limited to laboratory supplies, study documents and investigational product
• Responsible for all site management activities related to site activation and work with the sites to meet clinical project timelines and milestones
• Support the study Start-up team by following up on pending documents, as needed
• Support the Regulatory team by reviewing, localizing and translating site documents, as required
• Optimize patient recruitment providing guidance and support to site teams to meet the site recruitment milestones
• Participate in Investigator’s meetings

Mentoring and Internal Initiatives (5-10%)

• Mentor and support CRA I and II

Additional Responsibilities

• Perform CRA Assessment Visits, co-monitoring visits or visit sign-off process, providing feedback
• Assist the MSM hiring Manager by participating in interviews with candidates for the CRA position, as requested.
• Participate in process improvement initiatives and contribute to the development of best practices

Qualifications

MINIMUM EXPERIENCE REQUIREMENTS

4 - 6 years of related experience

PREFERRED EXPERIENCE REQUIREMENTS

7 – 9 years of related experience

MINIMUM EDUCATION REQUIREMENTS

(Honors) Bachelor’s degree

PREFERRED EDUCATION REQUIREMENTS

Master’s degree

LANGUAGE REQUIREMENTS

Fluent in written and verbal English

Or an equivalent combination of education and experience may be considered.

ADDITIONAL KNOWLEDGE / SKILLS

Health Sciences, Life Sciences, Pharmacy or Nursing degree preferred, or Sr.CRA and/or ACRP Certification/Designation.

Experience with Phase I–IV clinical trials is preferred.

Thorough knowledge of ICH-GCP and local regulatory requirements.

Proficient in using EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite.

Ability to travel up to 40-60%, depending on project assignment and geographic location of sites.

Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams.

Great communication and organizational skills, detailed orientation and sense of urgency are required.

Holder of a valid driver’s license.

Working Conditions

• Home-based
• Regular travel is required

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.