Senior Clinical Research Associate

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Implements and oversees clinical trials to ensure that the obligations of sponsors and investigators are fulfilled and compliant with relevant local regulatory standards and ICH Good Clinical Practice (GCP) guidelines.

• Evaluates the qualifications of potential investigative sites, initiates clinical trials at these sites, instructs site personnel on the proper execution of clinical trials, and concludes trials at investigative locations.

• Conducts site startup activities, including the collection of regulatory documents, reviewing informed consents, supporting IRB/IEC submissions, and negotiating budgets and contracts.

• Reviews and confirms the accuracy of clinical trial data collected either onsite or remotely.

• Provides regular updates on site status to team members and trial management while updating trial management tools.

• Completes monitoring activity documentation as required by sponsor standard operating procedures (SOPs).

• Collaborates with clinical team members to address trial and clinical issues.

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

• Conducts essential document site file reconciliation, source document verification, and query resolution.

• Evaluates investigational product accountability, dispensation, and compliance.

• Validates serious adverse event reporting in accordance with trial specifications and ICH GCP guidelines.

• Maintains communication with investigative sites and updates relevant tracking systems.

• Ensures that required training is completed and properly documented.

• Operates with minimal oversight at a senior level and may act as a subject matter expert.

• May be assigned to manage complex studies and/or sites.

• Provides leadership for assigned clinical operations projects.

• Acts as the observation and performance visit leader.

• Collaborates with other functional areas to resolve site issues and facilitate trial timelines.

⛳️ Requirements

• An undergraduate degree or its equivalent in a clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (e.g., registered nurse) or equivalent work experience is required.

• 2-5 years of clinical monitoring experience is required (CRA 2).

• 5+ years of clinical monitoring experience is required (Sr CRA).

• Knowledge of ICH and local regulatory authority regulations pertaining to drug development is essential.

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

• Oncology monitoring experience is required.

• Experience in feasibility/site selection/site startup is essential.

• Experience with budget negotiations is preferred.

• To be eligible, applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status.

• Employment with ICON is contingent upon possessing the legal right to work in the country where the role is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.