Inhouse CRA
3 weeks ago
About:
The Senior Clinical Research Associate (CRA) will directly report to the Senior Director of Clinical Operations. This role entails supporting the company’s clinical operations function in close coordination with research, development, and other departments. The responsibilities include collaborating with the study team, vendors, and clinical study sites to ensure adherence to SOPs, regulatory guidelines (ICH/GCP/CFR), and company objectives, timelines, and budgets.
The Senior CRA will be responsible for executing operational plans for clinical studies, leading site training, patient recruitment, data collection, and source data verification. They should have extensive experience in life sciences and clinical operations within the biotech or pharmaceutical industry, preferably with rare disease indications.
Desired characteristics for a good cultural fit include collaboration, strong organizational and communication skills, strategic thinking, independence, problem-solving ability, urgency, creativity, and positivity.
Responsibilities include all aspects of study site management, building and maintaining relationships with key site staff, investigator recruitment, IRB/EC submissions, CRF review, patient recruitment planning, risk identification, maintaining tracking systems, ensuring GCP compliance, managing clinical trial supplies, and accountability for site timelines.
Qualifications
- BA/BS degree (advanced degree preferred), 3-4 years of onsite clinical monitoring experience,
- monitoring and site management skills
- knowledge of monitoring procedures and drug accountability
- proficiency in SAE reporting, rare disease clinical research knowledge, gene therapy/gene editing experience preferred
- pediatric/hospital-based study experience desired, experience in global clinical trials, strong understanding of FDA and ICH/GCP/CFR regulations
- ability to work in a team, meet deadlines, prioritize tasks, inspire trust
- maintain integrity, and willingness to travel domestically and internationally up to 20%.
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Inhouse CRA
2 weeks ago
Blue Bell, United States Meet Full timeAbout: The Senior Clinical Research Associate (CRA) will directly report to the Senior Director of Clinical Operations. This role entails supporting the company’s clinical operations function in close coordination with research, development, and other departments. The responsibilities include collaborating with the study team, vendors, and clinical study...
