Global Study Associate, Oncology Clinical Operations
Global Study Associate, Oncology Clinical Operations (Gaithersburg, MD)
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with integrity, in every situation because we are committed to doing the right thing. We are committed to advancing the science of oncology to deliver life-changing medicines to patients with a pipeline that exploits the power of four scientific platforms (Tumour Drivers and Resistance, DNA Damage Response, Immuno-Oncology, Antibody-Drug Conjugates, Epigenetics and Cellular Therapy). We transform clinical concepts into medicines that deliver benefits to patients.
The Clinical Project Coordinator, Oncology Clinical Operations is responsible for supporting the Clinical Operations Team members with the tasks associated with implementation and conduct of clinical studies. Qualified candidates will demonstrate the ability to coordinate and prioritize multiple tasks, have good computer skills, and practical clinical trial experience.
JOB DUTIES & RESPONSIBILITIES
- Maintain trial master file, study site records and files and ensure compliance with applicable SOPs
- Create, implement, and maintain systems to track study metrics and general information (ex. OPAL and IMPACT, etc.)
- Coordinate generation of study metric reports and action logs
- Review of essential study documents
- Process study-related documents and materials - to include collation, filing, routing coordination of third-party provider document shipments to MedImmune
- Initiate contract/budget requests and track ongoing status
- Schedule team meetings and prepare agendas and minutes
- Prepare and distribute study-related correspondence
- Organize and ship study supplies to clinical sites
- Participate in identification and selection of clinical study sites, including conducting searches of web-based databases
- Develop study specific procedures and tools
- Assist clinical operations team with study management
- Participate in vendor selection and ongoing vendor management
- Generate purchase orders, process vendor invoices and assist in tracking spend against approved budget
- Assist in the organization of advisory boards and investigator meetings. Track approvals and completion of required documents.
- Assist in the clinical trial insurance process. Track approvals, revisions and renewals of certificates
- Perform other functions as necessary or as assigned
QUALIFICATIONS & EXPERIENCE
- HS Diploma is required; Bachelor’s Degree preferred
- 2-3 year’s clinical trial experience and at least 1 year experience in an office or laboratory environment
- Professional demeanor and ability to work as a team member
- Experience with Microsoft Office Suite (Word, Power Point, Excel)
- Ability to coordinate and prioritize multiple tasks
- Demonstrated verbal and written communication skills
- Demonstrated interpersonal and problem solving skills
- Proactive approach and the ability to act independently, or as part of a diverse team
- Understanding of ICH, GCP and relevant regulatory requirements
- Familiarity with drug names, diagnoses and medical/research terminology
- Ability to work as part of a global team
- Willingness to travel to attend periodic meetings.
Percentage of Travel: <10%
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.