Study Start Up Associate II - Home Based (San Diego, CA)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Study Start Up Associate II
Responsibilities:
Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with Client’s SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
Perform timely and accurate task progress communication and data entry of all relevant study start up activities into the appropriate tracking system.
Coordination of all necessary translations required for any start-up documentation.
Attend study team meetings as required.
Responsible, as assigned, for one or more of the following tasks related to each of the key study start- up and/or maintenance activities:
Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF):
Prepare, review and approve Global Master ICF templates for Sponsors.
Prepare, review and approve Country Master ICF templates inserting any required country elements. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.
Proficiently negotiate Informed Consent Forms (ICF) with Study Sites to ensure the Site Specific ICF meets local requirements and contains all required elements from Country Master ICF. Escalates any legal or clinical language discrepancies with Legal and/or Clinical team for approval as applicable.
Proficiently review, negotiate and approve all Ethics Committee (EC), Institutional Review Board (IRB) and Competent Authority (CA) queries to Country and Site Specific ICFs.
Proficiently prepare, review and approve amended Global, Country and Site Specific amended ICFs.
Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions:
Proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
Effective interaction with Ethics Committees, Institutional Review Boards and Country Regulatory Agencies (Competent Authorities) to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct (start up and maintenance as assigned).
Forecast submission/approval timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
Preparation, Submission, Review and Approval of Critical Document Package (CDP):
Proficient essential document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements and ICH/GCP guidelines.
Preparation and submission of site level critical documents which are part of the Critical Document Package (CDP) to the Central CDP Review Team (CDPRT) and Sponsor.
Review and approval of Critical Document Package (CDP).
Investigational Product (IP) release in accordance with regulatory and Sponsor requirements.
Accurately forecast CDP Approval timelines and ensure they are reflected accurately in Client’s systems, proactively follow through for achievement to plan; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.
Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control
(QC) review of files before transfer to maintenance for filing in TMF.
Qualifications:
Bachelor's degree in life sciences or a related field.
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
Ability to work on site in San Diego hybrid remote.
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
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 entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here
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.
Are you a current ICON Employee? Please click here to apply
