Job Description
The Role:
The Clinical Trial Associate (CTA) is responsible for assisting and providing support to the members of the clinical operations project team to support the management of clinical trials from initiation to completion while partnering with internal and external cross-functional disciplines. The CTA assists in supporting the conduct of trials and may be responsible for managing specific study and operational tasks.
What You’ll Do
- Perform quality control review of documents
- Perform sample management
- Maintain study trackers and tools as directed
- Assist study team with preparation for audits/inspections
- Track 1572s and liaise with Regulatory for IND submission as well as other essential documents as appropriate
- Responsible for filing documents in the Trial Master File for the study
- Responsible for agendas and meeting minutes for cross functional team meetings
- Support site start-up activities
- Perform Trial Master File (TMF) QC
- May assist in creating, editing, and distributing informed consent templates, manuals and other study documents
- May participate in review of study core documents (protocol, IB, CSR)
- May manage ancillary vendors
- May develop and maintain study documents
- Perform administrative task on assigned clinical trials
- Demonstrates excitement around the Vison and Mission of Deciphera and the department
- Other duties as assigned
Qualifications
What You’ll Bring:
- Bachelors or Masters degree with 2+ years of relevant experience
- Working knowledge of key regulations, ICH Guidelines and GCPs
- Demonstrates ability to learn tools and processes that increase measured efficiencies of the project
- Demonstrates ability to manage components of clinical trials with general guidance from senior staff
- Demonstrates understanding of interdependencies of data, technology, vendor metrics and differences across vendor abilities and requirements
- Strong verbal, written and presentation skills
Additional Information
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $82,000.00 - $113,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera’s competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).
Benefits
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
