Clinical Research Associate

Real Staffing; Chicago (IL); On-site; USD 70,000 - 110,000; Full time

Job summary

Specialist Staffing Group is seeking a Clinical Study Site Management professional in the United States. The role focuses on safeguarding participant safety, ensuring data integrity, and operationally supporting multicenter clinical trials.

You will verify regulatory compliance, manage site performance, and coordinate with Investigators, IRBs, vendors, and internal teams. The incumbent will also assist in site training, recruitment efforts, and CAPA implementation while upholding the Johnson &

Qualifications

Responsibilities

• Ensure that all work related activities embody Johnson & Johnson Credo values.
• Verify safety and well being of study subjects at assigned sites.
• Support operational execution of clinical trials and ensure high-quality data collection.
• Execute clinical trials activities following SOPs, GCP and regulatory requirements.
• Accountable for study site performance and data quality according to timelines.
• Assist Clinical Operations staff and site staff to resolve issues and implement CAPAs.
• Verify Investigator Site Files are maintained according to regulations and company procedures.
• Support patient recruitment and retention activities.
• Perform site visits and ensure site compliance with protocol and regulations.
• Assist with internal communication of important clinical data and events.
• Support Investigator and study training meetings as required.
• Act as a reliable resource of up-to-date study site status for stakeholders.
• Understand business value of clinical projects and balance business objectives.
• May be involved in other tasks to support Clinical Operations and the company.
• Support the implementation of new clinical systems/processes.
• Interface with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.
• Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• May be asked to provide additional support to Clinical Operations staff, as needed.

Job description

Key Job Activities:
Clinical Study Site Management Tasks:

• Ensures that all work related activities, and decisions embody the Johnson & Johnson Credo Values.


• Verify safety and well being of study subjects are maintained for assigned study sites.


• Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.


• Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.


• Accountable for study site performance, and providing high quality data according to overall project timeline.


• Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.


• Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.


• Responsible for supporting patient recruitment and retention activities.


• Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.


• Assists with internal communication of important clinical data and events.


• Support organization of Investigator and other study training meetings, if required.


• Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.


• Understand business value of clinical projects and balances overall business objectives and functional needs.


• May be involved in other tasks to support Clinical Operations and Operating Company as needed.


• Support the implementation of new clinical systems/processes.


• Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.

Administrative Tasks:

• Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.


• May be asked to provide additional support to Clinical Operations staff, as needed.

EOE Statement:

Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.