Site Activation Specialist 1
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Job Overview:
Under moderate supervision executes the feasibility site identificationregulatory start-up and maintenance activities in accordance withregulations SOPs and project requirements at the regional or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains reviews and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project moderate oversight and supervision perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international
regulations standard operating procedures (SOPs) project requirements and contractual/budgetary guidelines. May also include maintenance activities.
Essential Functions:
With moderate oversight and supervision serve a Single Point of Contact (SPOC) to perform feasibility site activation and some maintenance activities in assigned studies for investigative sites according to applicable regulations SOPs and work instructions working closely with the Site Activation Manager (SAM) Project Management team and other departments as necessary. Review documents for completeness consistency and accuracy under guidance of senior staff.
Prepare site documents reviewing for completeness and accuracy.
Inform team members of completion of regulatory contractual. and other documents for individual sites.
Distribute completed documents to sites and internal project team members.
Update and maintain internal systems databases tracking tools timelines and project plans with accurate and complete project specific information.
Review track and follow up the progress the approval and execution of required documents such as questionnaires CDAs regulatory ethics Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
Qualifications:
Bachelors Degree Life Sciences or a related field.
1 - 3 years clinical research or other relevant experience.
Basic knowledge of and skill in applying applicable clinical research regulatory requirements (i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
Good therapeutic and protocol knowledge as provided in company training.
Computer skills including proficiency in use of Microsoft Word Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers managers and clients.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.
Required Experience:
IC
Key Skills
- Business
- Marketing
- Key Decision Makers
- Active Directory
- Customer Service
- Performance Evaluations
- Federal Regulations
- Communications
- Account Management
- Project Management
- Minimum Data Set
- Budget management
- Powerpoint
- Direct Reports
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
