Job Description
Our client, a biotechnology company in Philadelphia, is seeking a Clinical Research Associate to support clinical trials from initiation through closeout. This role involves site monitoring, data review, and ensuring compliance with FDA regulations and Good Clinical Practice guidelines. The position reports to the Clinical Operations Manager and partners with sites, investigators, and cross-functional teams.
The ideal candidate has experience monitoring Phase I-III clinical trials and strong knowledge of regulatory requirements. This is a hybrid position with approximately 50% travel to clinical trial sites in the region.
Responsibilities
- Conduct site initiation, monitoring, and closeout visits
- Review source documents and verify data accuracy in case report forms
- Ensure compliance with study protocols, GCP guidelines, and regulatory requirements
- Build and maintain relationships with site staff and investigators
- Identify and resolve site-level issues and protocol deviations
- Prepare monitoring visit reports and track action items to resolution
- Support audit readiness and respond to audit findings
- Participate in investigator meetings and study team training
Requirements
- Bachelor's degree in Life Sciences, Nursing, or related field
- 3+ years of clinical monitoring experience
- Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial processes
- Experience with electronic data capture systems such as Medidata or Veeva
- Excellent organizational and time management skills
- Strong written and verbal communication skills
- Ability to travel up to 50% regionally
- ACRP or SOCRA certification preferred
Benefits
- Competitive base salary with annual bonus potential
- Medical, dental, and vision insurance
- 401(k) with company match
- Hybrid work schedule with flexibility
- Generous paid time off and company holidays
- Travel expense reimbursement
- Life and disability insurance
- Professional development opportunities
Job Type: Full-Time | Work Type: Hybrid | Industry: Pharmaceutical | Experience: Mid-Senior
Job Tags
Full time,