At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.
Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.
Study Start Up Associate II
As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
The Role
* To review and negotiate clinical site investigator contracts and budgets.
* Stay connected with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents
* Prepare and coordinate preparation of contractual documents and correspondence
* Facilitate the indemnification process between the study sponsor and the site.
* Function as the internal consultant on study budgets (investigator payments, develop and update training documentation and conduct group training as necessary, mentor and train new and junior personnel in the SSU department, and act as consultant on the Investigator Contract and Budget development process from origination through execution).
Other Job roles available
2. Regulatory and EC submissions
Perform feasibility, site identification, site contract negotiation, and other study start up activities, as assigned * *Prepare, review and submit submissions to CA, EC and other relevant authorities in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct. This includes, but it is not limited to: * ethics/regulatory/other relevant authority approvals for clinical trials A Symbol of Excellence * ethics/regulatory/other relevant authority approvals for trial amendments * ethics/regulatory/other relevant authority study notifications * authorizations for import/export of investigational products, clinical supplies and biological samples * approvals from the national authorities for data protection * *Review and translate Drug Labels * *Advise Sponsor on knowledge content for development of Drug Labels * *Perform independent quality review of submission packages * *Responsible for the collection and maintenance of the current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant ICON information system * *Responsible for the translation and co-ordination of translations for documents required for submission * *Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system * *Copy and route incoming correspondence, internal documentation, etc., as appropriate * *Responsible for the timely follow-up for queries made by EC/CA * *Responsible for the collection of critical documents required for IP Release * *Attend study team meetings as required (maybe discretionary), including Kick-Off Meetings which are mandatory * Assemble and distribute study materials to Clinical and Project teams, including materials to study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as appropriate * *To be familiar with ICH GCP, relevant country regulations/guidelines and ICON SOPs * Competent in communication skills for timely follow-up, issue resolution and report updates; as outlined in the communication and escalation plan with timely documentation * To undertake other reasonably related duties as may be assigned from time to time
3. Critical Document Package Review
- Perform high quality CDP reviews according to the process defined in SOP SST004 titled "Critical Documents Collection, Critical Document Package (CDP) Approval and IP Release. Provide SSU Lead/designee with CDP Requirement Sheet to discuss with the Sponsor.
- Update CDP Requirement Sheet during the start-up phase of studies in consultation with the SSU Lead/designee. Customize final Critical Document Package/IP Release Checklist and Global CDP Review Worksheet including any Sponsor, Country and Study Specific requirements.
- Complete CDP reviews within defined and agreed timelines of receipt by the CDP Review Team/designee.
- Complete review of CDP documents alongside the supporting Critical Document Package/IP release Checklist to confirm all the CDP documents are complete, consistent, current and in accordance with ICH/GCP and all applicable regulations, laws, and other guidelines and ethical standards.
- Return to CDP Submitter any documents identified as incomplete, not current or inconsistent. Sign and date the "Approved By" section of the Critical Document Package/IP Release Checklist to confirm approval of CDPs which are complete, consistent, current and in accordance with ICH/GCP and all applicable regulations, laws and other guidelines and ethical standards.
- Enter details of CDP review into the CDP Approval Tracker at completion of each review. Upload approved CDPs to agreed electronic filing system.
What you need
* A bachelor's degree in Paralegal Studies, Juris Doctor (law) degree, or related experience is preferred
* SSU experience is desirable but not required.
* Experience in a clinical research environment with specific experience in study contracts review and budget negotiation or in related field such as where contract or legal document review is a primary part of you role.
Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and 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.
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