Clinical Research Associate - 0.2 FTE - Italy

Join ProPharma as a Clinical Research Associate

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.

Role: Experienced Clinical Research Associate (CRA) supporting one site in Italy.

Contract: Initial 1-year contract at 0.2 FTE.

Responsibilities

• 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 like monitoring guidelines, plans, and Informed Consent Form (ICF) templates.
• 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, and CRA evaluations at study sites as required.
• Writes trip reports or evaluation reports and follow-up letters for study visits.
• 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 training of vendors and study coordinators on study requirements.
• May train site staff on protocol specific issues, GCPs or other necessary training.

Qualifications

• Bachelor's degree or equivalent combination of education and experience.
• Must have 2+ years of experience as a Clinical Research Associate.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
• Ability to travel.
• Electronic data capture (EDC) experience required; CTMS and IVRS system experience is a plus.
• Rare disease or Pediatric experience preferred.

Our Commitment

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.

"Working at ProPharma has allowed me to be part of groundbreaking advancements in healthcare, while being supported in a diverse and inclusive environment."
John Doe, Clinical Operations Manager