Icon plc is a world-leading healthcare intelligence and clinical research organisationFrom molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our successIcon people have a mission to succeed and a passion that ensures what we do, we do well.
Responsibilities
What you will be doing:
Clinical trial coordinator (ctc)
Trial and site administration:
Track (e.gEssential documents) and report (e.gSafety reports)
Ensure collation and distribution of study tools and documents
Update clinical trial databases (ctms) and trackers
Clinical supply & non-clinical supply management, in collaboration with other country roles
Manage labeling requirements and coordinate/sign translation change request
Document management:
Prepare documents and correspondence
Collate, distribute/ship, and archive clinical documents, e.gEtmf
Assist with etmf reconciliation
Execute etmf quality control plan
Update manuals/documents (e.g., patient diaries, instructions)
Document proper destruction of clinical supplies.
Prepare investigator trial file binders
Obtain translations of documents
Regulatory & site start-up responsibilities: collaborate with other country roles to:
In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
Obtain, track and update study insurance certificates
Support preparation of submission package for irb/erc and support regulatory
Agencies submissions.
Publish study results for gcto and ra where required per local legislation
Budgeting, agreement and payments:
Collaborate with finance/budgeting representatives for:
Develop, control, update and close-out country and site budgets (including split site budget)
Develop, negotiate, approve and maintain contracts (e.gCtras)
Track and report contract negotiations
Update and maintain contract templates (in cooperation with legal department)
Calculate and execute payments (to investigators, vendors, grants)
Ensure adherence to financial and compliance procedures
Monitor and track adherence and disclosures
Maintain tracking tools
Meeting planning:
Organize meetings (create & track study memos/letters/protocols)
Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
Quality & oversight: (for senior ctc level)
Contribute strongly to ctc team knowledge by acting as process subject matter expert (sme), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
Mentors / buddies junior ctcs (including, but not limited to process requirements)
Qualifications
What you need to have:
Clinical trial coordinator (ctc)
Minimum 1-2 yrs in clinical research or relevant healthcare experience
Completed job training (office management, administration, finance, health care preferred) or b.a./b.s(life science preferred) or equivalent healthcare experience
Good understanding of global, country/regional clinical research guidelines and ability to
Work within these guidelines.
Hands on knowledge of good documentation practices
Good it skills (use of ms office, use of some clinical it applications on computer) and ability to adapt to new it applicationsStrong ms excel skills required.
Ich-gcp knowledge appropriate to role
Excellent negotiation skills for ctcs in finance area
Highly effective time management, organizational and interpersonal skills, conflict management
Effective communication with external customers (e.gSites and investigators)
High sense of accountability / urgencyAbility to set priorities and handle multiple tasks simultaneously in a changing environment
Works effectively in a matrix multicultural environmentAbility to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to customer focus, both internally and externally.
Able to work independently taking full ownership of delegated tasks
Proactive attitude to solving problems / proposing solutions
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
Icon is an eeo/aa employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
Benefits of working in icon:
Our success depends on the knowledge, capabilities and quality of our peopleThat’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At icon, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programsIn addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Icon, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassmentAll 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.
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