Company: Confidential
Job Title: Sr. Clinical Research Associate
Job Number: 36134
Location: ,
Job Description
In this role, you will partner with a full-service CRO to manage and oversee clinical studies, ensuring data quality and patient safety in line with ICH-GCP guidelines and local regulations. You will also support day-to-day clinical study activities in collaboration with the clinical team.
Responsibilities
- Partner with a full-service CRO to monitor trials, ensuring compliance, data accuracy, and site relationship management.
- Conduct site visits to assess protocol and regulatory compliance, and maintain required documentation.
- Build collaborative relationships with sites and study vendors.
- Support the clinical study manager with monitoring visit report reviews and other tasks.
- Develop monitoring tools for the team to assist with data review.
- Track enrollment reports to ensure study sites meet enrollment goals.
- Support study sites with audits/inspections and quality issues as needed.
- Review outstanding data reports to ensure timely data collection.
- Perform Serious Adverse Event reconciliation and resolve discrepancies with sites.
- Collaborate with team members to achieve study goals.
- Perform additional duties as required.
Required Skills
- Bachelor's degree with 6 years of clinical trial industry experience.
- At least 3 years of monitoring experience, including 2 years in oncology monitoring.
- Experience managing multiple complex oncology studies simultaneously.
- Proven ability to build relationships with investigator sites and vendors.
- Strong knowledge of ICH/GCP and relevant regulations.
- Detail-oriented with a focus on quality and compliance.
- Ability to travel up to 50%.
- Proficient in Microsoft Office, EDC, CTMS, eTMF, and other technologies.
Apply for job
To apply for this job please visit k7y.pl.