Ref #: 38821

Employment type: Permanent - Full-Time

Location: Home office

Posted: 05-Aug-2022

Description

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON is partnering with one of the most successful global biotechnology companies to support them in developing new drugs in critical areas to increase health and quality of live all over the world. To accomplish this we are currently looking for an experienced In House CRA/Site Activation Sepcialist (m/f/d) 100% Home based.

The Senior Site Activation Specialist is responsible for site start-up activities for the assigned studies within the Site Alliance and Site Activation Sub-Chapter under Clinical Operations. The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, Study Teams, and Sites.

Key Responsibilities include:

- Site Activation:
- Work with investigator sites to complete critical information for site activation; inclusive of, but not limited to, Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB - submission and status
- Coordinate Investigator Review Board (IRB)/Ethics Committee (EC) /other relevant regulatory submissions in collaboration with sites/study teams
- Support contract and budget negotiations in partnership with Contracting and Study Teams.
- Supports the pre-study site identification/selection process for relevant studies through collection and analysis of site feasibility information.



To Be Successful in The Role You Will Have

- Associate or Bachelor’s degree in chemistry, biology, other life sciences, or a related field, or equivalent combination of education and experience
- Experience in study start-up for a minimum of 5 years
- Experience in clinical trial planning, including IRB/Ethics Committee and contracts
- Knowledge of clinical trial methodologies, medical terminology, ICH/GCP
- Must be fluent in English, and the language of the appointed location
- Working knowledge of global and local regulatory requirements is nice to have
- Required to support multi-national team members, and flexibility in working hours may be needed.



What is Offered

- Work for one of the global top two CROs, sponsor dedicated in one of the global top pharmaceutical companies fully integrated and from the sponsor’s perspective
- Permanent contract (full time)
- Homeoffice 100%, no travel required
- Thorough onboarding training under mentorship
- Excellent career options


Sounds like a good fit? Get in touch with me today!

Please submit your CV to nadine.rabenstein@docsglobal.com or via our homepage www.ICONplc.com/FSP. We are looking forward to your application.


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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