CRA for the EN)

Job Description

Responsibilities

• Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. On average 3 site visits per month.
• Serves as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed.
• Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns.
• Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc.
• Performs study-related training.
• Manages the development and maintenance of study documents, processes and systems as assigned.
• Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals.
• Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance.
• Provides all job-related progress reports and visit documentation as required.
• May support safety activities such as narrative writing, managing the CEC/DSMB, etc.
• Prepares and coordinates submissions to regulatory authorities.
• Assess the suitability of potential investigative sites through screening interviews, regulatory document review and evaluation of study information and provides input to the site selection process.
• Assists with the coordination of the site budget and contract negotiations as directed by the project lead(s).
• Assists in preparing sites for audits and in resolving audit action items.
• Supports sites during audits remotely and/or onsite as needed.
• Participates in meetings with prospective clients.
• Supports training and mentoring of CRAs during remote and onsite visits.
• Manages the development and/or maintenance of study monitoring plan, templates, trackers, study tools, and site-specific documents.
• Assists Clinical Study Manager (CSM) with development of human clinical protocol, investigational plan/brochure, SIV training presentations, and study operations development.
• Supports Core Laboratory management and may serve as the primary contact.
• Supports data management in CRF development, validation rules, UAT, review data and identify trends, and other reporting/analysis tasks.
• Performs and summarizes literature searches.
• Registers trials on Clinicaltrials.gov
• May perform other activities as assigned.

Requirements

• Higher education degree or equivalent education, training, and experience
• Preferred 5 years clinical trial experience
• Preferred 3 years monitoring experience
• Fluency in English and Dutch
• Able to work independently once trained.
• Good verbal and written communication skills.
• Strong organizational skills.
• Basic computer proficiency.
• Understanding of clinical research processes and regulations.
• Existing right to work in Europe required

Benefits

• A balanced salary package based on your capabilities and experience

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