Senior In-House Clinical Research Associate

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Provide oversight for monitoring by evaluating reports and escalating issues related to data quality or trends in study conduct.

• Supervise the activities of CROs and study vendors to ensure compliance with protocols and timely achievement of clinical objectives and deliverables.

• Assist in the preparation of study documentation, which includes protocols, study manuals, informed consent forms (ICFs), study plans, and case report forms (CRFs).

• Collaborate with CROs during the study start-up phase, site feasibility assessments, and selection of study sites.

• Coordinate clinical study activities alongside Clinical Operations and representatives from various functions.

• Ensure that study documentation is maintained in accordance with regulations, industry standards, and standard operating procedures (SOPs).

• Work together with Clinical, Regulatory, Quality, and other cross-functional teams to ensure compliance and readiness for inspections.

• Identify and address issues and deviations related to the study.

• Communicate effectively with study sites and investigators.

• Provide support to study sites through training and troubleshooting assistance.

• Organize meetings and document minutes for Clinical Operations.

• Conduct onsite or remote co-monitoring, training, motivational sessions, and sponsor oversight visits as required.

• Undertake additional duties that contribute to the success of the project.

⛳️ Requirements

• A bachelor's or master's degree in a relevant discipline such as life sciences, nursing, or pharmacy.

• A minimum of 2–3 years of experience in clinical research, ideally in a CRA or similar role.

• Familiarity with trial and site initiation, vendor selection and management, study oversight, monitoring, and study closure.

• Comprehensive understanding of clinical trial processes, Good Clinical Practice (GCP), FDA regulations, and ICH guidelines.

• Outstanding written and verbal communication abilities.

• Strong organizational skills for handling multiple tasks and priorities effectively.

• Keen attention to detail for ensuring accurate data collection and documentation.

• Proficiency in Microsoft Office applications.

• Experience with electronic data capture systems (EDC).

• Capability to foster positive relationships with study sites and investigators.

• Flexibility to adjust to evolving project demands and timelines.

• Strong team-oriented mindset and a commitment to ongoing personal development.

• Previous startup experience is preferred.

• Willingness to travel up to 10%, if necessary.

🏝️ Benefits

• Competitive benefits package.

• Paid time off (PTO).

• Stock option plans.

• Commitment to employee well-being and continuous growth opportunities.

• Recognized as a Great Place to Work-Certified™ company.