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About the Role
As the world’s largest FSP organisation, with over 90 sponsor partnerships, ICON offers stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
Responsibilities
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
- Assesses potential investigative sites, initiates trials, instructs site personnel, and closes trials.
- Responsible for site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations.
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely.
- Provides regular site status information to team members and trial management, and updates trial management tools.
- Completes monitoring activity documents as required by sponsor's SOPs.
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
- Escalates site and trial related issues per Sponsor's SOPs until resolved or closed.
- Performs essential document site file reconciliation.
- Performs source document verification and query resolution.
- Assesses investigational product (IP) accountability, dispensation, and compliance at investigative sites.
- Verifies serious adverse event (SAE) reporting according to trial specifications and ICH GCP guidelines.
- Communicates with investigative sites.
- Updates applicable tracking systems.
- Ensures all required training is completed and documented.
- Functions with little oversight.
- May serve as a subject matter expert for clinical operations on monitoring related activities.
- May be assigned to complex studies and/or sites.
- Provides leadership skills to assigned projects within the clinical operations department.
Requirements
- Highly responsive and proactive, team player.
- An undergraduate degree or its equivalent in a clinical, science, or health-related field from an accredited institution; a licensed health care professional or equivalent work experience required.
- 2-5 years clinical monitoring experience required (CRA 2 for sponsor).
- 5+ years clinical monitoring experience required (Sr CRA for sponsor).
- Knowledge of ICH and local regulatory authority regulations regarding drug.
- Read, write and speak fluent English.
- Oncology monitoring II/III experience required.
- Serves as observation and performance visit leader.
- Experience doing feasibility/site selection/site start up required.
- Budget negotiations experience preferred.
- May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
- May be assigned clinical tasks where advanced negotiating skills are required.
- 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 having the legal right to work in the country where the role is based.
Skills
- Clinical monitoring
- ICH GCP guidelines
- Site startup
- Regulatory document collection
- Informed consent review
- IRB/IEC submission support
- Budgets and contracts negotiations
- Data verification
- Investigational product (IP) accountability
- Serious adverse event (SAE) reporting
- Leadership skills
Location
- East Coast
Work Type
- Full-time
Experience Level
- Senior
- 5+ years clinical monitoring experience
- 2-5 years clinical monitoring experience
Education Level
- Undergraduate degree or equivalent in clinical, science, or health related field
- Licensed health care professional
Salary/Compensations
- $110,520.00-$138,150.00
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
About the Company
- At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
- As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
Equal Opportunity
- ICON is an equal opportunity employer.
- We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
- If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.