Freelance Senior Clinical Research Associate - Belgium and The Netherlands

Join ProPharma as a Senior Clinical Research Associate in The Netherlands & Belgium

About ProPharma

ProPharma partners with clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We have an immediate need for 2 SCRA's to join us on a Freelance basis in The Netherlands and covering both The Netherlands & Belgium.

The Senior Clinical Research Associate (SCRA) position is responsible for clinical monitoring for assigned protocols and investigational sites. The role ensures that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practices (GCP), and other applicable regulatory requirements.

Key Responsibilities:

• Responsible for conduct of all types of monitoring and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person and remotely. This includes evaluation, site initiation, interim, and close out monitoring visits.
• Write and complete monitoring reports within required SOP and local regulatory parameters.
• May be responsible for performing study start up activities in accordance with local practice, including site identification and feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set up activities (Ex-US).
• Support development of study specific documentation related to monitoring activities, such as monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets.
• Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements.
• Review source documents and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues.
• Manage, prepare, send, track, and return investigational supplies as assigned, including monitoring and documenting investigational supplies dispensing, inventory, and reconciliation.
• Monitor assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities, and any other activity at the site that contributes to proper conduct of the clinical trial per protocol and regulatory requirements.
• Review and oversee regulatory documentation for accuracy and completeness and support assigned clinical sites with any regulatory concerns as appropriate.
• Communicate with assigned clinical sites, investigators, site personnel, client personnel, and any other cross functional team member involved in the assigned clinical trials to address any study needs related to the monitoring and site management activities.
• Participate in meetings and conference calls with internal project teams, Sponsor teams, and any external partners working on execution of the assigned clinical trial.
• Other duties as assigned.

Necessary Skills and Abilities:

• Excellent verbal, written communication skills, interpersonal, and presentation skills.
• Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations.
• Experience with Electronic Data Capture (EDC), CTMS, IVRS, and eTMF required.
• Knowledge of applicable local law, local regulatory requirements and regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
• Must be able to offer solutions when obstacles are identified and train as necessary to achieve project goals.
• Must have a general understanding of routine project goals from an organizational perspective.
• Strong organizational skills and attention to detail required. Ability to prioritize and plan workload is essential.

Educational Requirements:

• Bachelor's degree or equivalent combination of education and experience.

Experience Requirements:

• More than 5 years of experience as a Clinical Research Associate.