Freelance Senior Clinical Research Associate - Germany, Austria & Switzerland - 0.3-0.5FTE

Das ist der Job

ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.

Darum lohnt es sich

Responsibilities • Support development of study‑specific documentation related to monitoring activities, including monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets. • Provide site personnel management and training on protocol requirements, proper source documentation procedures compliance, and case report completion requirements. • Review source document 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, termination updates, protocol deviations, serious adverse events, laboratory abnormalities, and other site activities that contribute 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 cross‑functional team members involved in the assigned clinical trials to address any study needs related to monitoring and site management activities. • Participate in meetings and conference calls with internal project teams, sponsor teams, and external partners working on execution of the assigned clinical trial. • Perform other duties as assigned.

Company Overview For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies.

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.

Role Overview The Senior Clinical Research Associate 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.

Activities include conduct of all types of monitoring, co‑monitoring visits and associated monitoring activities for assigned clinical sites both in person and remote, evaluation, site initiation, interim and close‑out monitoring visits, monitoring report writing and completion within required SOP and local regulatory parameters, and study start‑up activities as applicable.

Required Skills and Abilities Excellent verbal, written communication, interpersonal, and presentation skills. Strong computer skills with experience using Microsoft Office (Outlook, Word, Excel, and PowerPoint) to prepare charts, tables, forms, reports, and presentations.

Experience with Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Interactive Voice Response System (IVRS), and electronic Trial Master File (eTMF). Knowledge of applicable local law, local regulatory requirements and regulations, ICH Guidelines, and GCP governing the conduct of clinical trials.

Ability to prioritize tasks, plan proactively, and accomplish goals using well‑defined instructions and procedures with minimal supervision. Ability to offer solutions when obstacles are identified and train as necessary to achieve project goals. General understanding of routine project goals from an organizational perspective.

Strong organizational skills and attention to detail. Ability to prioritize and plan workload. 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. #LI-EL1 Equal Opportunity Statement We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion.

Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. #J-18808-Ljbffr