Intern, Study Start Up

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.

We are now welcoming applications for Interns (6-months) in our office in Sofia, Bulgaria.

Office-based 5 days/week.

Summary:

The role will collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP. The employee is expected to embrace and where possible contribute to our culture of continuous process improvement with a focus on streamlining our processes, adding value to our business and meeting client needs.

Responsibilities:

• 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:

o Preparation, review and approval of Subject Information Sheets (SIS) and Informed Consent Forms (ICF):

o Be involved as required in the preparation, review and/or approval of Country Master ICF templates.

o 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.

o Review, negotiate and approve all Ethics Committee (EC) and Institutional Review Board (IRB) queries to Site Specific ICFs.;

o Prepare, review and approve amended Site Specific amended ICFs.o Negotiation and Execution of Clinical Trial Agreements (CTA):

o Prepare, review and negotiate CTAs, budgets and any required ancillary agreements with assigned Study Sites.

o Prepare and oversee all contractual documents and correspondence, including the facilitation of the indemnification process, between Sponsor and Study Site.§ Establish and maintain effective and proactive communication with Study Sites and internal personnel regarding the status of budgets, contracts and any other contract-related documents.

o Ensure CTAs, budgets and ancillary agreements are negotiated within the Study specific agreed parameters and if not appropriate approvals are obtained and documented.

o As required, prepare, review and negotiate amendments  to CTAs, budgets and ancillary agreements.

o Forecast Budget and Clinical Trial Agreements execution timelines and ensure they are achieved; provide risk and contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.

o Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions;

o 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.

o 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).

o Forecast submission/approval timelines and ensure they are achieved; provide contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.

o Preparation, Submission, Review and Approval of Critical Document Package (CDP).

o 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.

o 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.

o Review and approval of Critical Document Package (CDP).

o Investigational Product (IP) release in accordance with regulatory and Sponsor requirements.

o Forecast CDP Approval timelines and ensure they are reflected accurately in ICON’s systems and are achieved; provide contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified.

o Ensure accuracy and 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.

Requirements:

• Actively enrolled students in their last 2-3 years of studies. We are welcoming students in Medicine and Life Science;• Good communication skills;• Good judgment & decision making skills;• Proficient computer knowledge;• Proficiency in English;

• A prompt command of a second language - French, German, Italian or Dutch.

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.