Study Start Up Associate Ii

hace 3 semanas

Desde casa, México ICON A tiempo completo

Study start up associates are integral in ensuring that clinical research sites are prepared and have the necessary tools and approvals needed to start the trial. As a study start up associate at ICON working in contracts your main role is to review and negotiate clinical site investigator contracts and budgets. Maintain communication with Investigative sites, sponsors and internal personnel regarding the status of contracts and contract-related documents. Prepare and oversee preparation of contractual documents and correspondence. Facilitate the indemnification process between the study sponsor and the site. Serve as the internal consultant on study budgets with respect to investigator payments. Develop and update training documentation and conduct group training as necessary. Mentor and train new and junior personnel in the study start up department. Act as consultant on the Investigator Contract and Budget development process from origination through finalization.

We are looking for associates who have experience in a clinical research environment with specific experience in study contracts and budget development. Study start up experience is desirable.

We differentiate ourselves by developing innovative solutions to bring life-saving drugs to market faster in a more cost-effective way with better patient outcomes. We are a top five organization with solid earnings and growth potential. Our belief in excellence is our core value in all that we do for our sponsor partners and the patients that we serve. As a company we strive to exceed our customers’ expectations in drug development solutions.

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent retirement plan, private health care, and life insurance, and staff recognition schemes. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.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.
- **The Role**:
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.
- Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
- Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager - Central Services or Designee.

**What you need**
- A high school diploma or local equivalent
- Bachelor’s Degree preferably in Life Sciences
- Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities.
- Experience of Clinical Trial operations and meeting regulatory guidelines
- Proficient project management skills.

**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

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