Clinical Research Associate- CA/CO Posted Date 3 days ago(12/31/2024 9:43 AM) ID 2024-115910 Location : Location US-CA- Location : Location US-CO- Overview
As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencingAbility to effectively manage multiple priorities and responsibilities of increasing scope and complexity.Strong planning & organizational skills, and the ability to work efficiently and effectively Proactive, conscientious and precise in delivery of quality work even when under pressureEffective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely mannerFlexible with high learning and change agilityKnowledge of local regulations, IND/ICH GCP - guidelines,Available and willing to travel as job requiresCommunicate the progress and relevant information or escalate issues of the study to the appropriate study management teamEngage and maintain good written and verbal communication with external stakeholders in order to ensure effectivenessAccountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriatePerforms operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-outDetermines the feasibility of the study protocol with reference to study complexityConfirms staff availability, suitable clinical facilities, potential for per protocol patient populationConfirms ability to comply with ICH GCP and requirements for clinical studies.Works with Study staff to carry out a local study / site level riskParticipate in global investigators and/or monitor meetings as appropriate. Facilitates investigator’s participation in global meetings and/or may assist the study staff with organizing local investigator Participates in other study meetings as required.Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones areEnsure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to safety department and other relevant departments, within the required time frames.Completes monitoring visit reports within the agreed timelinesEnsure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Ensure all unused study supplies are accounted for and destroyed appropriately.Ensure sponsor study records are inspection ready at all times and archives records as applicable Qualifications
You are:
Education required:
Undergraduate degree or its international equivalent in clinical, science, or health-related fieldfrom an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience preferred
Skills Required
Read, write and speak fluent English; fluent in host country language required.2-4 years of clinical monitoring experience requiredKnowledge of ICH and local regulatory authority regulations regarding drugClinical research experienceKnowledge of ICH and local regulatory authority regulations regarding drugExperience in monitoring all trial components (PSSV to COV)Experience in coaching/mentoring other CRA
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlementsA range of health insurance offerings to suit you and your family’s needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-beingLife assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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