Senior Clinical Research Associate - Oncology - Baltimore, MD or Phila, PA ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients…
Skills: Oncology clinical trials, Site management, Clinical monitoring, Data integrity, Subject safety
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Full-time
bachelor degree
Medical coverage, Dental coverage, Vision coverage, Retirement plans, Pension plans, Life assurance
Posted 15d ago
~40 hrs/week
Remote in Baltimore, Maryland, United States, Philadelphia, Pennsylvania, United States
Responsibilities
The Senior Clinical Research Associate is responsible for performing investigative site management and monitoring activities to ensure data integrity and subject safety throughout the clinical trial lifecycle. They will act as the primary contact for sites, facilitate communications, and support regulatory inspections while maintaining inspection readiness.
Requirements
Candidates must have a Bachelor's degree and at least 5 years of experience in clinical trial monitoring, including specific experience in solid tumor and oncology trials. Proficiency in GxP, regulatory compliance, and site relationship management is required, with a preference for experience using Veeva systems.
Full job description
Senior Clinical Research Associate - Oncology - Baltimore, MD or Phila, PA
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle. This Sr. CRA role will support the client's Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness at the clinical investigative sites.
Responsibilities:
Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites
Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials
May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
Promptly document monitoring activities and submit/approve visit reports
Manage site essential document collection and TMF reconciliation with site files
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
Support sites and the client's regulatory inspections
Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
Lead site engagement initiatives and foster relationships with key Oncology sites and networks
Qualifications
Bachelor’s degree (scientific field preferred)
5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials.
1+ years early development oncology trial experience and/or Phase III Oncology trial experience
Solid tumor clinical trial experience is required
Experience utilizing Veeva systems is highly preferred
Demonstrated experience developing/maintaining site relationships and securing compliance
Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
Experience collaborating with sites from initial engagement through close-out phases
Experience activating sites
Experience training site staff
Experience supporting sites and/or sponsors in regulatory inspections
Experience working within a Functional Services (or in-house) monitoring model is preferred
Willing to travel up to 50%
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
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.
Are you a current ICON Employee? Please click here to apply
Related keywords
OncologyClinical Research AssociateSite ManagementMonitoringData IntegritySubject SafetyInspection ReadinessVeevaGxPRisk-Based MonitoringCAPAProtocolSOPGCPIRBEthics Committee
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
Medical DeviceTherapeuticsGovernment and Public Health SolutionsClinical Research ServicesCommercialisation and OutcomesOncologyValue Based HealthcareClinical TrialsPatient RecruitmentInnovation
How many Science & Research jobs are open in Baltimore, MD right now?
There are currently 886 open science & research positions in Baltimore, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Science & Research roles in Baltimore, MD?
Companies currently hiring include John Hopkins University, University System of Maryland, Northrop Grumman, Northrop Grumman Mission Systems, Inc., University of Maryland Medical System, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Science & Research jobs in Baltimore, MD?
Yes — 225 of the 886 open science & research positions offer remote or hybrid work (54 remote, 171 hybrid).
How do I apply for Science & Research jobs in Baltimore, MD?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.