Senior Clinical Research Associate – Contractor

This is a fully remote position, open to applicants in Netherlands.

📋 Description

• Conduct feasibility assessments for prospective sites.

• Execute pre-study activities, initiate studies, perform interim monitoring, and carry out site close-out visits.

• Serve as the Lead CRA for international studies and manage a team of CRAs.

• Create Clinical Monitoring Plans.

• Evaluate site visit trip reports.

• Mentor and provide guidance to less experienced CRAs and site personnel.

• Develop study-specific tools and templates.

• Engage in study team, investigator, and bid defense meetings.

• Design and deliver training for study team members and fellow colleagues.

• Collaborate with Project Management to assess deliverables and study milestones.

• Compile documentation for regulatory and ethical submissions.

• Coordinate the shipment and receipt of study materials.

• Document findings from site visits in written reports.

• Contribute to the design of protocols and CRFs.

• Evaluate, monitor, and train site staff on adherence to protocols.

• Review safety information and informed consent documents.

• Perform source document verification.

• Review CRFs and assist in resolving data queries.

• Support the maintenance of the Investigator Site File.

• Maintain consistent communication with study sites.

• Update site-related documentation for inclusion in the Trial Master File.

• Ensure compliance at sites regarding investigational product receipt, accountability, and return or destruction.

• Conduct accompanied visits to sites for CRA assessment or training.

• Complete final site close-out visits and prepare reports.

• Undertake additional assigned responsibilities.

⛳️ Requirements

• MD, Pharmacist, or equivalent pharmacy degree with a minimum of 3 years of experience as a Clinical Research Associate; OR

• A four-year degree in medical, biological, physical, health, pharmacy, or a related science with at least 5 years of Clinical Research Associate experience; OR

• A two-year college degree or equivalent education/training, with a minimum of 7 years of Clinical Research Associate experience.

• A nursing degree or equivalent life science degree is preferred for candidates with a two-year degree.

• Willingness to travel.

• Valid current passport.

• Driving license.

• Fluency in the local languages of the countries under responsibility.

• Proficient in spoken and written English.

• Outstanding oral and written communication skills.

• Exceptional planning, organizational, and time-management abilities.

• Strong interpersonal skills.

• Initiative and problem-solving capabilities.

• Ability to lead and inspire an assigned team, if necessary.

• Capacity to provide experience and insights into process initiatives related to monitoring and site management.

• Comprehensive understanding of clinical research principles and processes.

• In-depth knowledge of FDA and/or EU directives and regulations, ICH Guidelines, and local regulatory requirements.

• Solid understanding of two to three therapeutic areas to effectively function as Lead CRA.

• Thorough knowledge of standard operating procedures.

• Proficiency in Microsoft Office.

• Experience with IxRS and EDC systems.

🏝️ Benefits

• A diverse and inclusive workplace.

• Supportive and cohesive team environment.

• Accessible and hands-on leadership.

• Equal employment opportunities.

• Exceptional employee experiences.

• Opportunities for mentoring and professional growth through guidance and training activities.