Senior Clinical Research Associate

This is a fully remote position, open to applicants in New Jersey, +2 more states.

📋 Description

• Execute and oversee clinical trials to ensure compliance with sponsor and investigator responsibilities, as well as adherence to relevant local regulations and ICH GCP guidelines.

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

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

• Review and authenticate clinical trial data gathered either onsite or remotely.

• Provide consistent updates on site status and refresh trial management tools accordingly.

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

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

• Escalate site and trial-related issues until they are resolved or formally closed.

• Reconcile essential document files for each site.

• Conduct source document verification and resolve queries.

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

• Verify the reporting of serious adverse events in accordance with trial specifications and ICH GCP guidelines.

• Maintain communication with investigative sites and update tracking systems as necessary.

• Ensure that required training is completed and properly documented.

• Operate with minimal supervision at a senior level.

• Act as a subject matter expert for senior-level clinical operations monitoring activities.

• Work on complex studies and/or sites as assigned.

• Provide leadership for designated clinical operations projects.

• Lead observation and performance visits.

• Assist in resolving site issues and facilitating trial timelines across different functional areas.

⛳️ Requirements

• A highly responsive and proactive team player.

• An undergraduate degree or equivalent in a clinical, science, or health-related field from an accredited institution, or a licensed healthcare professional, or equivalent work experience.

• 2–5 years of clinical monitoring experience is required for CRA 2 positions.

• 5+ years of clinical monitoring experience is necessary for Senior CRA roles.

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

• Proficiency in reading, writing, and speaking fluent English.

• Required experience in oncology monitoring for Phase II/III trials.

• Experience as an observation and performance visit leader is necessary.

• Required experience in feasibility studies, site selection, and site startup.

• Budget negotiation experience is preferred.

• Advanced negotiating skills may be essential for assigned clinical tasks.

• Legally authorized to work in the United States.

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

• Required training must be completed and documented.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans available.

• Life assurance and disability coverage provided.

• Employee assistance programs and wellness resources accessible.

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

• An inclusive and accessible workplace environment.

• Reasonable accommodations during the recruitment process offered.

• Commitment to sustainable business practices and community support.