What are the responsibilities and job description for the SCTA (Insource) position at Pharmaceutical Research Associates, Inc?
Overview
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.
Responsibilities
As a Sr CTA you will be working closely with the wider project team to support the management of investigative sites and ensure that all sites adhere to the requirements and regulations governing Clinical Research. You will receive comprehensive training which will enable you to learn, before moving to work on your own studies with continuing support, training and mentorship.
You will have the opportunity to work on clinical studies at different stages of the project lifecycle and gain a variety of therapeutic experience. The Sr CTA supports with feasibility, study start-up, assisting sites during maintenance and closing out sites.
Key responsibilities in this position include:
- Working within the framework of the study protocol, to assist with the preparation and organisation of investigator and study site materials both at a local and international level.
- Working closely with Clinical Team Managers, Start-Up Leads and Clinical Research Associates.
- Working with the wider PRA project team including Regulatory, Contracts and Project Management.
- Performing investigative site recruitment and evaluation.
- Essential document collection, review and maintenance.
- In-house site management activities and ensuring that all study files and documents are current and complete.
Qualifications
- An undergraduate degree or its international equivalent in clinical science or health related field who is keen to begin or develop your career within Clinical Research.
- 3 plus years of related experience required
- Experience leading a team in clinical research environment- required
- Exceptional inter-personal skills, a keen eye for detail and the ability to prioritise and multi task.
- The ability to learn new tasks and processes quickly in a fast-paced and dynamic environment.
- Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (CTMS, EDC and eTMF)
- Experience with Oncology preferred
- TMF experience-uploading documents
- Administrativ support- Meeting Minutes
- To qualify, applicants must be legally authorized to work in the Canada or the United States, and should not require, now or in the future, sponsorship for employment visa status.
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.