Clinical Research Associate at Real Staffing Group Chicago, IL

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

Job summary

Healing Strides Counseling seeks a professional to manage clinical study sites, ensure subject safety, and oversee data quality and regulatory compliance. You will coordinate with investigators and operations staff to uphold SOPs and ensure smooth trial execution.

You will also help with patient recruitment, site visits, and training coordination, while maintaining clear communication of important clinical data to stakeholders.

Qualifications

• No specific qualifications listed in the provided HTML.

Responsibilities

• Clinical Study Site Management Tasks: Ensure compliance with Credo Values, verify safety and wellbeing of study subjects, support operational execution of trials, collect high-quality data, follow SOPs/GCP/regulatory requirements, be accountable for site performance and data quality, resolve issues with Clinical Operations staff, verify Investigator Site Files are maintained, assist patient recruitment/retention, perform site visits and ensure protocol and regulations compliance, facilitate internal communication of clinical data, support Investigator and training meetings, maintain accurate site status, balance business objectives with functional needs, may assist with new systems/processes, interface with investigators, IRBs/ECs, contractors and staff.
• Administrative Tasks: Ensure compliance with laws and Health Care Compliance Program and Code of Conduct, provide additional support 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.
• To find out more about Real, please visit