Senior Clinical Research Associate

This is a fully remote position, open to applicants in Illinois, +3 more states.

📋 Description

• Execute and oversee clinical trials to ensure adherence to sponsor and investigator responsibilities, local regulations, and ICH GCP guidelines.

• Evaluate the qualifications of investigative sites and initiate, conduct, and conclude clinical trials at those locations.

• Carry out site startup activities, which include gathering regulatory documents, reviewing informed consent, supporting IRB/IEC submissions, and negotiating budgets and contracts.

• Review and validate clinical trial data either on-site or remotely.

• Provide updates on site status and manage trial management tools and tracking systems.

• Complete documentation of monitoring activities in accordance with sponsor Standard Operating Procedures (SOPs).

• Collaborate with members of the clinical team to address trial and clinical challenges.

• Escalate issues related to sites and trials until they are resolved or closed.

• Reconcile essential document site files, perform source document verification, and address queries.

• Evaluate accountability, dispensation, and compliance of investigational products.

• Verify serious adverse event reporting in line with trial specifications and ICH GCP guidelines.

• Communicate with investigative sites to ensure that required training is completed and documented.

• Work with minimal supervision and potentially act as a subject matter expert in clinical operations monitoring.

• Lead designated projects and assist with complex studies or sites.

⛳️ Requirements

• Bachelor’s degree or equivalent in a clinical, scientific, or health-related discipline from an accredited institution, or equivalent professional experience.

• Licensed healthcare professional, such as a registered nurse, or equivalent professional experience.

• Minimum of 5 years of clinical monitoring experience required for Senior Clinical Research Associate (CRA) level.

• Familiarity with ICH and local regulatory authority regulations related to drugs.

• Proficient in reading, writing, and speaking English.

• Experience in monitoring oncology Phase II/III trials.

• Previous experience leading observation and performance visits.

• Background in feasibility, site selection, and site startup.

• Legally authorized to work in the United States.

• Must not require current or future sponsorship for employment visa status.

• Experience in budget negotiation is preferred.

• Advanced negotiation skills may be necessary for assigned clinical tasks.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Reasonable accommodations provided during the recruitment process.