Job Title: Freelance Clinical Research Associate (Dutch)

Overview:

Entrust Resource solutions are looking to hire a Freelance Clinical Research Associate (Dutch)to join a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Our client look to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease, where they are looking for individuals to add to their CRA team.

Responsibilities:

The primary responsibilities of this position include, but are not limited to, the following:

·        Act as the routine liaison between study site and the project team for study related issues.

·        Ensures protection of subjects, subjects' rights and the integrity of data through monitoring of adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures and protocol compliance.

·        Conduct pre-qualification, initiation, routine monitoring and close-out visits in accordance with the relevant SOPs.

·        Source document review and comparison to CRF data

·        CRF review/retrieval and data corrections

·        IMP accountability

·        Maintenance of on-site investigator files

·        IEC/IRB documentation

·        Local laboratory documentation

·        Maintenance of investigational supplies

·        Reviews consent process for each subject (Informed Consent Form and source documentation)

·        Verify patient eligibility

Assess protocol compliance and deviations

Handling of safety and efficacy issues, including, but not limited to:

·        Serious adverse event reports

·        Adverse event trends

·        Treatment failures

Conducts and documents onsite visits/contacts, including:

·        Pre-study visits 

·        Initiation visits

·        Routine visits

·        Study completion visits

·        Telephone contact

·        Site visit report preparation within study specific timeframe
Responsible for all aspects of site management as described in the study plans

·        Proactively identify and resolve issues and potential site and study issues.

·        Assist with regulatory and study start-up activities including contract and budget negotiations, as required.

·        Ensure clinical data integrity and meet study timelines.

·        Provide ongoing updates and support to project management.

·        Function as a lead monitor for assigned projects, as required

·        Perform Assessment and Training Visits

·        Mentor junior members of the team.

·        Prepare and deliver staff training sessions.

·        Clinical Review of individual patient listings

·        Initial clinical review of comprehensive patient data listings

·        Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars

·        Assist in the day to day running of projects assigned.

·        Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc.

·        Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc.

·        Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.

·        Perform other duties as assigned by management

Qualifications:

Level of Education:

• At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field or equivalent experience

Prior Experience:

• At least 4 years’ experience as a Clinical Research Associate with a sound track record in managing clinical trial sites
• Experience in monitoring oncology early phase studies

Skills and Competencies: 

• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
  Highly effective multitasking and execution skills.
• Excellent interpersonal skills, including communication, presentation, persuasion, and influence.
• Excellent organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems
• Effective knowledge of the drug development process and the Theradex organizational structure
• Strong communication skills: verbal/written
• Proficient knowledge of Outlook, Word and Excel

Additional Requirements:

• This position involves international and/or national travel as needed to meet study requirements
• Ability to travel approximately 85% of the time domestically and/or internationally and may involve overnight stays.
• Valid Driver’s License and Passport preferable
• Successfully pass background clearance checks which may be run on a periodic basis due to 3rd party contractual obligation requirements
• Fluent in English and Dutch

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