ICON plc

Senior Clinical Research Associate

ICON plc • $95K — $115K *
Florida, NY 10921In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Undergraduate degree in clinical, science, or health-related field or equivalent experience.
  • 2-5 years of clinical monitoring experience required for CRA 2; 5+ years for Sr CRA.
  • Proficient knowledge of ICH and local regulatory requirements regarding drug trials.
  • Prior oncology monitoring II/III experience essential.
  • Ability to read, write and speak fluent English.

Responsibilities

  • Implement and monitor clinical trials to meet compliance with regulatory and GCP guidelines.
  • Assess and qualify potential investigative sites, initiating and closing trials at these locations.
  • Manage site startup activities including regulatory documentation, consent reviews, and contract negotiations.
  • Review and ensure accuracy of clinical trial data collected both onsite and remotely.
  • Provide updates on site status to team members and trial management.

Benefits

  • Collaborative and dynamic work environment.
  • Opportunities for professional growth and advancement.
  • Participation in complex and significant clinical studies.
  • Flexible work arrangements to accommodate personal needs.
Full Job Description
Senior Clinical Research Associate - Oncology - East Coast

What you will be doing:
  • Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
  • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites.
  • Responsible for site startup activities for assigned sites, including but not limited to regulatory documents 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, 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 identified issues are 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 the 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 (Sr level)
  • May serve as a subject matter expert for clinical operations on monitoring related activities (Sr level)
  • May be assigned to complex studies and/or sites.
  • Provides leadership skills to assigned projects within the clinical operations department.


What you need to have:
  • Highly responsive and proactive, team player
  • An undergraduate degree or its equivalent in clinical, science, or health related field from an accredited institution; a licensed health care professional (i.e. registered nurse) 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.
  • To qualify, 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

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Healthcare
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ
ICLR
* Ladders Estimates

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