CRA - Monitor West/Mountain

System One, Inc.; Philadelphia (Philadelphia County); On-site; USD 55,000 - 85,000; Part time

Job summary

System One is seeking an Oncology Clinical Study Monitor on a part‑time basis. You will manage sites for oncology trials, ensure protocol and regulatory compliance, and drive data integrity and patient safety.

The role combines onsite and remote monitoring and requires strong communication and planning skills. Candidates should have a health‑care background with a degree (nursing preferred) and 5+ years of oncology monitoring experience, including hematology and myeloma or lung cancer contexts.

Qualifications

• Bachelor's degree or nursing degree required.
• Strong health‑care background with oncology monitoring experience preferred.
• Knowledge of ICH/GCP and regulatory requirements. SOCRA/ACRP certification preferred.

Responsibilities

• Monitor sites to ensure protocol adherence and data integrity.
• Coordinate with Sponsor and sites; prepare reports and attend calls/meetings.
• Travel approximately 60%; conduct onsite and remote monitoring as needed.

Skills

Healthcare background

Autonomy

Communication skills

Problem-solving

Site management

Education

College degree or nursing degree

Tools

Medidata RAVE

Job description

Oncology Clinical Study Monitor- PART TIME

Key responsibilities-- general site management, including but not limited to:

• Ensuring sites meet study qualifications, monitoring of assigned study sites according to the monitoring plans, ensuring timely data submission and query resolution.
• Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, Global and local regulations to secure data integrity and patient safety.
• Frontline liaison for Sponsor and sites to ensure successful collaboration.
• Responding to site questions, and preparation of reports.
• The study monitor will be an integral part of the study team matrix and will also need to prepare for and participate in calls/meetings.
• Candidate should expect to travel approximately 60% of the time. A valid driver’s license will be necessary.

Experience:

• The candidate must have a strong health-care related background with a college degree or be a graduate of an accredited school of nursing. At least five years prior to oncology monitoring experience is required with hematology study experience multiple myeloma and small cell lung cancer backgrounds
• The candidate must demonstrate professionalism, exemplary planning skills, and be able to work with autonomy and minimal supervision.
• Good communication skills, identification of key issues and trends, and problem-solving are integral to success in the position.
• Knowledge of ICH, GCP, safety and other regulatory requirements is key; certification from SOCRA or ACRP is preferred.
• He/she must have computer competency and should be familiar with data management systems (i.e., Medidata RAVE).
• Experience in related fields such as pharmaceutical, data management, and technical writing is a plus.

Ref: #568-Clinical