Clinical Research Associate

Real; Chicago (IL); On-site; USD 70,000 - 100,000; Full time

Job summary

Real is seeking a Clinical Operations Specialist to manage study sites and ensure compliance with GCP, regulatory requirements, and the Johnson & Johnson Credo Values in a Chicago area role. You will coordinate site activities, support patient recruitment, and help drive data quality across trials.

The role requires at least a bachelor's degree in a life/biomedical field, 2+ years in clinical research, and the ability to travel up to 80% to support multiple sites and stakeholders.

Qualifications

• Bachelor's degree in Life Science, Physical Science, Nursing or Biological Science.
• Minimum 2 years of relevant clinical research experience.
• Previous medical device monitoring or equivalent experience is preferred.
• Understanding regulations and standards in clinical research and medical devices.
• Certifications such as CCRA, RAC or CDE are preferred.

Responsibilities

• Ensures adherence to Johnson & Johnson Credo Values in all site activities.
• Verifies safety and well-being of study subjects at assigned sites.
• Supports operational execution of clinical trials and ensures high-quality data collection.
• Follows SOPs, GCP, and regulatory requirements for trials.
• Maintains Investigator Site Files per regulations and company procedures.
• Assists with patient recruitment/retention activities and site training.
• Travels up to 80% to manage study sites and support sponsors.

Skills

Leadership

Communications

Presentation

Organization

Travel readiness

Education

Bachelor's degree

Tools

Microsoft Office

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.

Desired Skills and Experience

Education

• A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.

Experience

• Typically requires Bachelors degree with at least 2 years of relevant experience; Masters or PhD/MD/PharmD with at least 1 year of relevant experience.


• Previous clinical research experience required.


• Previous medical device monitoring or equivalent experience required.


• Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.


• Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).


• Clinical/medical background - a plus.

Knowledge

• Requires experience and knowledge working with computer systems (Microsoft Office - Excel, Word, and Power Point).

Additional Requirements

• Demonstrated competencies in the following areas are required:
  
  
  
  • Leadership
  
  
  • Written and verbal communications
  
  
  • Presentation and influencing
  
  
  • Strong organizational skills (e.g., able to manage multiple sub-projects and tasks simultaneously and consistently meet all associated deadlines).
  
  
  • Ability to travel up to 80% of time.
  
  
  
  

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.