CRA - Monitor West/Mountain

System One

Philadelphia, PA
1 day ago
Remote

Highlights

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. At least five years prior to oncology monitoring experience is required with hematology study experience multiple myeloma and small cell lung cancer backgrounds.

Numbers & Facts

Location	Philadelphia, PA ( Remote)
Industry	Staffing/Employment Agencies
Company Size	2,500 to 4,999 employees
Website	https://systemone.com

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.

About Company

Every day, System One focuses on services and solutions that require a high degree of specialization, in-demand technical skills, and large-scale operational expertise. We are essential partners to those on the front lines of our nation’s most critical infrastructure, technology, and life sciences initiatives.

Founded more than 40 years ago as a staffing partner to the engineering industry, today System One is a diversified organization operating in over 50 locations and putting more than 9,000 people to work in the United States, Canada, and the United Kingdom.