CRA - Monitor Great Lakes / Midwest

System One, Inc.; Philadelphia (Philadelphia County); On-site; USD 83,000 - 124,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Spending accounts

Life insurance

Voluntary plans

401(k) plan

Job summary

System One is seeking an experienced Contract Clinical Research Associate/Study Monitor to oversee oncology trials in the Great Lakes/Midwest region. This remote/offsite position requires about 60% travel and a 20+ hour week.

Ideal candidates hold a college healthcare degree, at least five years of oncology monitoring experience, and familiarity with ICH/GCP. SOCRA/ACRP certification is a plus; Medidata RAVE experience is helpful; strong communication and autonomy are essential.

Qualifications

• At least five years of oncology monitoring experience.
• Experience with site management and data submission.
• SOCRA/ACRP certification preferred.
• Knowledge of ICH/GCP and regulatory requirements.
• Proficient with data management systems (e.g., Medidata RAVE).

Responsibilities

• Manage study sites per monitoring plans and qualifications.
• Conduct onsite and remote monitoring activities.
• Ensure protocol compliance, data integrity, and patient safety.

Skills

Oncology monitoring

GCP knowledge

Data management

Communication

Autonomy

Education

Bachelor’s degree or nursing degree

Tools

Medidata RAVE

Job description

Job Title: Clinical Research Associate
Location: Great Lakes/Midwest Region
Type: Contract
Hours: 20+ hours/week

Overview

Seeking an experienced Contract CRA/Study Monitor to oversee oncology clinical trial site management across the Great Lakes/Midwest region, ensuring protocol/GCP compliance, data integrity, and patient safety. This is a remote (offsite) contract role requiring ~60% travel and 5+ years of oncology monitoring experience; SOCRA/ACRP certification is a plus.

Responsibilities

• General site management, including ensuring sites meet study qualifications, monitoring assigned study sites according to monitoring plans, ensuring timely data submission and query resolution.
• Conduct continuous monitoring activities (onsite and remote).
• Implement site management activities to ensure compliance with protocol, GCP, global, and local regulations to secure data integrity and patient safety.
• Serve as frontline liaison for Sponsor and sites to ensure successful collaboration.
• Respond to site questions and prepare reports.
• Prepare for and participate in calls/meetings as part of the study team matrix.
• Travel approximately 60% of the time; a valid driver’s license is necessary.

Requirements

• Strong healthcare-related background with a college degree or graduation from an accredited school of nursing.
• At least five years of oncology monitoring experience, including hematology study experience with multiple myeloma and small cell lung cancer backgrounds.
• Demonstrate professionalism, exemplary planning skills, and ability to work with autonomy and minimal supervision.
• Good communication skills, ability to identify key issues and trends, and effective problem-solving.
• Knowledge of ICH, GCP, safety, and other regulatory requirements; certification from SOCRA or ACRP is preferred.
• Computer competency and familiarity with data management systems (e.g., Medidata RAVE).

System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including

• medical
• dental
• vision
• spending accounts
• life insurance
• voluntary plans
• participation in a 401(k) plan

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical