Study Start Up Associate Ii

6 months ago

Remote, India ICON Full time

**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).**:
**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**:
***What you need**:

- ** Need **biology background, like BAMS, Pharma, MSc clinical research etc.**:

- ** 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.**:

- ** Knowledge of ICH GCP and Prior clinical research experience with a minimum of 4-7 years’ experience in Essential Document review, filing documents in TMF and checking TMF completeness and readiness.**:
**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.**
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