Clinical Trial Specialist
This client is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, client is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.
We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!
Position Summary
The Clinical Trial Specialist (CTS) is a member of the Clinical Operations team and is responsible for providing operational support for the day-to-day management of one or more global clinical trials in cooperation with the Clinical Operations team leaders. This position reports to the Senior Director, Clinical Project Management.
Key Responsibilities- Ensures timely and accurate study document creation in cooperation with the Clinical Project Lead and Site Relationship Manager, including but not limited to study manuals, newsletters, presentations, study-specific plans, case report forms and support materials
- Assists in reviews of country and site-specific Informed Consent Forms and site budgets
- Coordinates/schedules meetings with external and internal project teams and vendors. Distributes agendas, takes/distributes meeting minutes and provides follow up correspondence as needed
- Reviews essential documents required for IRB/EC submission and IMP delivery and follows up with CRO if missing or corrected documents are required
- Creates and maintains study trackers, such as but not limited to documents version tracker, lab shipments, equipment requests, enrollment, team rosters, site contracts and budgets, team training
- Additional duties as designated by the Clinical Project Lead
Qualifications- B.A. or B.S. degree, preferably in a scientific discipline
- A minimum of 3 years of industry experience in a pharmaceutical /biotech or CRO as a CTS or Clinical Trial Assistant or Clinical Site Study Coordinator experience
- Solid understanding of ICH guidelines and regulatory requirements for clinical trials
- Strong organizational skills, and attention to detail
- Proficiency with computer software including MS Office applications and SmartSheet
- Excellent written and verbal communication skills.
- Comfortable working in a demanding, fast-paced, start-up culture with evolving processes. Flexible and able to adapt to new situations as the business demands.
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 accommodationrequest@advancedgroup.com.
