The CRA is a seasoned professional with wide-ranging experience and a thorough understanding of GCP and ICH principles. The experienced CRA identifies and resolves complex issues where an analysis of situations and data requires an in-depth evaluation of multiple factors. Exercising sound judgement in selecting methods and techniques and evaluating criteria for resolving issues, the CRA will establish strong, positive relationships with both internal and external partners. This individual contributes to the determination, development and/or implementation of efficient and effective approaches to study site management.
Main activities are:
Responsible for evaluating, initiating, monitoring and closing out clinical study sites. Documents all activities in clear, comprehensive and accurate Monitoring Visit Reports, Contact Reports and follow-up letters within required timelines.
Ensures that the conduct of clinical studies at sites is in accordance with the protocol/protocol amendments, Good Clinical Practice regulations, International Harmonization Guidelines, applicable company Standard Operating Procedures (SOPs), and all applicable regulatory requirements.
Properly trains/re-trains site personnel on the protocol/protocol amendments, systems utilized in the study, and all operational aspects of the trial.
Serves as primary contact for site personnel, acting as liaison between site personnel and sponsor study team members.
Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines.
Ensures subjects’ rights, safety and well-being are protected.
Ensures compliance with the procedures to apply in the event of adverse events and serious adverse events.
Evaluates the quality and integrity of reported data, ensuring that sites enter data into EDC and resolve queries in a timely fashion.
Assists Data Management in development, review and/or testing of eCRFs and eCRF Completion Guidelines. Also supports data validation and data cleaning procedures to ensure timelines are met.
Identifies, assesses and resolves site performance, quality or compliance problems and develops an appropriate intervention plan for the avoidance of redundant errors and deviations.
Communicates with Investigators, site staff, Sponsor Study Team Members, and/or QA on issues related to protocol conduct, subject recruitment and retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Maintains audit-ready clinical trial documentation. Collects, reviews, monitors, and files required regulatory documentation during study maintenance and at study closeout. Verifies investigator study records are reconciled with the contents of Sponsor files (Trial Master File).
Verifies the receipt, handling, accounting, storage conditions and availability of study medications under investigation.
Ensures availability of non-clinical materials for sites.
Demonstrates strong site relationships and ensures continuity of site relationships through all phases of the trial.
Demonstrates an in-depth understanding of study protocols and related procedures.
Contributes to CRA team knowledge by acting as process and/or system Subject Matter Expert (SME), sharing best practices; developing new process(es), when needed; making recommendations for continuous improvement
Providing training/coaching/mentoring to other CRAs as needed.
Assists in developing presentations for internal team and Investigator meetings.
Assumes responsibility of and independently completes special projects, if assigned, with minimal monitoring management guidance.
Qualifications
Position requires BA/BS preferably in the Life Sciences
Minimum of 2+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research Associate from study start-up to database lock
Proficient in speaking and writing Dutch & French
Strong Oncology monitoring experience in phase 1-3 pharmaceutical/biotechnology clinical trials
Demonstrated high level of monitoring skill with independent professional judgment
Possess excellent understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
Strong knowledge of concepts of clinical research and drug development
Strong working knowledge of EDC, IVRS and CTMS systems
Proficient in the use of Microsoft Office
Ability to work highly independently across multiple studies, projects and sites. Ability to work effectively in a team/matrix environment. Ability to understand technical, scientific and medical information.
Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills
Demonstrated ability to mentor/lead
Works with high quality and compliance mindset
Possess a valid driver’s license
Must be willing to travel and spend 8-10 days /month on site.
What we offer:
We offer a competitive salary package with extra-legal benefits (possibility to telework and have flexible working hours, 32 days of holiday per year, company car and fuel card, hospitalization and groups insurance, lunch vouchers , eco vouchers, mobile phone (data included).
We commit to support you to perform your assignment under the best conditions (personal coaching, job relevant support / training, 360 degree year end review, ...)
Side activities will be organised regularly, to achieve a close collaboration within our team
We want to be innovative with our work culture so we involve our consultants, building our company structure & strategy.
We contribute to a number of charities & support the research and / or the patients in our industry.
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