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 remotelyProvides 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 systemsEnsures 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 playerAn undergraduate degree or it’s equivalent ence, or health related field from an accredited institution; a licensed health care professional (i.e. registered nurse) or equivalent work experience required.5+ years clinical monitoring experience required (Sr CRA)Knowledge of ICH and local regulatory authority regulations regarding drugRead, write and speak fluent English.Oncology Phase II/III monitoring experience requiredServes 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 should not require, now or nsorship for employment visa statusRewards & BenefitsICON 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 incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.Visit our
careers site to read more about the benefits ICON offers.Inclusion and AccessibilityICON 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.Salary Range$110,520.00-$138,150.00
22 days ago