Site Activation Specialist/Senior Site Activation Specialist (US/Remote)
Location: Morrisville, NC, USA
Requisition Number: 993
Position Title: Site Activation Specialist
Who we are
We’re the Uncommon CRO!
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way!
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What Site Activation does at Worldwide Clinical Trials
Site Activation is the perfect place to develop and further your career. We emphasize development of project management and strategic planning skills that will advance you though the opportunities within Site Activation or serve as an excellent pathway to advancement in Project Management or other Clinical Operations groups.
What you will do
As a Site Activation Specialist, you are responsible for supporting Site Activation, Regulatory and Maintenance activities with emphasis on the quality and delivery of the Essential Document Packet. Responsibilities include Essential Document collection, tracking, review and provision of country/site requirements to support achievement of site activation goals and IRB maintenance activities in compliance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs).
Tasks may include but are not limited to:
- Track study-specific site regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the Site Activation Manager
- Support the adaptation of country/site specific informed consent forms
- Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
- Interface with relevant functional leads to ensure appropriate prioritization of essential document collection and review to facilitate synchronized start-up
- Collect, receive, and perform first review of required study-specific site regulatory/essential in accordance with applicable SOPs, guidelines and relevant study specific plans. Implement corrective action as needed, prior to essential document review sign off and follow up on Non-Hold items post sign off (where applicable)
- Where applicable, provide local follow up and updates of status of local EC submissions to the Regulatory Affairs and relevant teams assigned to the project
- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate
- May perform pre-award feasibility studies
- Support Site Identification activities including the collection of Confidential Disclosure Agreements and the collection and analysis of Site Identification Questionnaires
- Support the collection of country and site level intelligence
- May support the development of a preliminary potential site list
- Support translations according to governing SOPs
- May help train Site Activation colleagues to foster quality delivery throughout the department
- May support regulatory activities under guidance as needed for critical delivery or for professional self-development if desired
- Be familiar with and comply with SOPs, ICH GCP and applicable regulations
- Maintain an understanding of FDA regulations, ICH Guidelines and country/local regulatory requirements.
OTHER SKILLS AND ABILITIES:
- Organizational and time management skills
- Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills
- Self-motivated learning about current regulatory processes and intelligence accompanied by knowledge sharing and training within and beyond the SAR department team
- Strong written and verbal communication skills to clearly and concisely present information
- Easily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and quality
- Strong ability to handle multiple tasks in a fast-paced and changing environment
- Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint
- Aptitude for contemporary digital systems is helpful
- Team-oriented work style; seeks and gives guidance to others
- Strong understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
- Strong understanding of clinical research principles and process
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum one year of experience in clinical research, preferably in site activation or regulatory-related function
- Previous experience within the pharmaceutical/CRO industry
- Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance
- Multilingualism preferred; fluent in local language; working knowledge of English
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
State: North Carolina
Employment Type: Regular
Community / Marketing Title: Site Activation Specialist/Senior Site Activation Specialist (US/Remote)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Research Triangle Park (RTP), North Carolina US
CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.