Summary of the Essential Functions of the Job:
| Under the guidance of SSU and Study Support management this position will be responsible for conducting end-to-end site start-up (from feasibility to site activation) serving as the primary point of contact for study team. Responsibilities include supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and executing site start-up activities. |
Duties and Responsibilities:
- Serve as primary point of contact to study team on end-to-end start up activity
- Participate in or lead Study-Start-up team meetings as appropriate
- Utilize Study Start-Up tools to track activities and develop reports
- Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and management of Feasibility Tools
- Conduct site contract and budget negotiations (Confidentiality Agreement and Clinical Trial Agreements)
- Collect, track and review essential documents from sites and perform required quality reviews.
- Support the collection of country and site level intelligence
- Complete, manage and/or support Ethics Committee and Regulatory Authority submissions
- 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
Qualifications (Minimal acceptable level of education, work experience, and competency):
- BA/BS degree in Science or related field
- Proficient in the English language
- Thorough understanding of clinical research principles and process
- At least 5 years experience in site start-up and contract management in pharmaceutical company or in clinical research organization
- Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures
- Thorough understanding of ICH Guidelines and country/local regulatory requirements
- Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
- Proficient in MS Office Suite (Outlook/Calendaring, Word, Excel, PowerPoint and Project), and strong email, presentation, documentation, and interpersonal skills
- Excellent oral and written communication skills
|
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].