Clinical Research Associate

Oxford Global Resources - Malvern, PA

Full-time - Entry Level

Malvern, PA

Administrative and Support Services

About the position

The Clinical Research Associate (CRA) position involves supporting the Clinical Affairs team to ensure compliance with Good Clinical Practices, federal regulations, and Clinical Affairs SOPs during the study site selection and conduct. The role includes both in-house and on-site monitoring to facilitate the successful execution of clinical studies.

Responsibilities

• Conduct pre-study visits to assess site facilities, staff, and subject population adequacy.
• Coordinate the distribution of supplies to study sites and maintain adequate inventory during the study.
• Track the distribution and return of all study materials and drugs.
• Perform site initiation to ensure compliance with protocols and regulations.
• Conduct interim site monitoring visits and document findings in monitoring reports.
• Perform close-out visits to all study sites.
• Assist in maintaining Trial Master Files (TMFs).
• Prepare informed consent forms (ICFs), case report forms (CRFs), and study support documents.
• Review site-generated ICFs for compliance with protocols and regulations.
• Provide feedback on data management documents to the Clinical Trial Team Lead.
• Review pharmacovigilance plans and provide feedback to the Clinical Trial Team.
• Evaluate and recommend investigators/study sites for selection.
• Train investigators and trial staff in data collection methods to ensure accuracy and compliance.
• Ensure collection and review of essential documents as defined by FDA regulations.

Requirements

• 2+ years of relevant working experience in a clinical research setting at a CRO or an R.N. or Bachelor's degree in biological sciences or related healthcare field.
• Working knowledge of FDA CFRs and Good Clinical Practice Guidelines related to CRA activities.
• Proactive and able to work independently and collaboratively with teams.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office (Word, Outlook, and Excel).
• Ability and willingness to travel up to 50% of the time.

Benefits

• Supplemental medical, dental, vision, life, and disability benefit plans.
• 401(k) Retirement Savings Plan.
• Paid holidays based on eligibility.
• Paid sick leave as required by applicable jurisdiction.