Clinical Research Associate

vor 2 Wochen

Berlin, Deutschland ProPharma Group Vollzeit

For the past 20 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. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its 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.

ProPharma are looking for an experienced CRA to join their team. This CRA will be supporting German trial sites and will cover Austria as required. The Clinical Research Associate (CRA) is responsible for clinical monitoring for assigned protocols and investigational sites. The CRA reports to the Monitoring Manager or designee and is responsible for ensuring that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practices (GCP) and other applicable regulatory requirements.

This role will require availability of approximately 0.5 FTE and the role will be offered on a 2 year initial contract. Dermatology or Oncology experience is preferred.
- Essential Functions Include:

- Supports the clinical team in clinical monitoring and operational study execution of assigned protocol and sites.
- May assist in the design and development of study related documents including (but not limited to) monitoring guidelines, monitoring plans, CRA evaluation plans, Informed Consent Form (ICF) templates, Case Report Forms (CRFs), CRF guidelines/instructions Data Management Plans, source document templates, monitoring visit report templates, site tools and worksheets.
- Assist in the review and tracking of regulatory documents and other study related documents.
- Creates, maintains and reports metrics for monitoring study visit reports and study data.
- Conducts all types of monitoring, co-monitoring, CRA evaluations at study sites as required by the Sponsor and SOW including Phase I unit pre-study evaluations. Provides visit feedback for evaluation by the Clinical Operations group/or designee.
- Writes trip reports or evaluation reports and follow-up letters as required by SOPs for study visits. Also responsible for the tracking of all study visits and reports and make sure they are consistent with the monitoring plan.
- May assist in the review of required documents for Clinical Trial Material (CTM) release authorization.
- Performs data review, query generation and query resolution.
- Participates in meetings and conference calls with internal project teams, Sponsor teams, and external partners.
- May participate in the training of vendors, and study coordinators on study requirements. May be required to train site staff on protocol specific issues, GCPs or other necessary training.
- May be asked to review time sheets and expense reports for CRAs. Must ensure consistency with contract and travel policy.
- Bachelor's degree or equivalent combination of education and experience.
- Must have extensive experience as a Clinical Research Associate.
- Ability to travel.
- Electronic data capture (EDC) experience required and CTMS and IVRS system experience is a plus.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- 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.

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