Clinical Trial Associate

Deciphera Waltham , MA 02154

Posted 2 days ago

Company Description

Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera's switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.

See here for more details on our portfolio.

We offer an outstanding culture and opportunity for personal and professional growth guided by our "PATHS" Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune's Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.

Job Description

We are seeking a Clinical Trial Associate (CTA) to assist and provide support to the members of the clinical operations project team in order to facilitate the management of the clinical trial processes, including planning and execution of clinical trials. The CTA assists in supporting the conduct of trials and may be responsible for managing specific study and operational tasks.

What You'll Do:

  • Maintain study trackers and tools as directed by the CPM

  • Support site start-up activities

  • Assist study team with preparation for audits/inspections

  • Assist in creating, editing, and distributing informed consent templates, manuals and other study documents

  • Track 1572s and liase with Regulatory for IND submission as well as other essential documents as appropriate

  • Perform Trial Master File (TMF) QC

  • Perform quality control review of documents

  • Assist with sample management

  • May provide study-specific training and mentoring to CRAs and site staff

  • May develop and maintain study documents

  • May participate in review of study core documents (protocol, IB, CSR)

  • Demonstrates excitement around the Vison and Mission of Deciphera and the department

  • Other duties as assigned

Qualifications

What You'll Bring:

  • Bachelor's degree

  • 1+ years of hands on clinical research experience either at an academic center, CRO or Pharmaceutical/Biotech company

  • Excellent communication (oral and written), organizational, and problem-solving skills

  • Strong attention to detail

  • Excellent Microsoft Office skills

Additional Information

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

  • Non-accrual paid time off

  • Summer vacation bonus

  • Global, company-wide summer and winter shutdowns

  • An annual lifestyle allowance

  • Monthly cell phone stipend

  • Internal rewards and recognition program

  • Medical, Dental, and Vision Insurance

  • 401(k) retirement plan with company match

  • Life and Supplemental life insurance for family

  • Short and Long Term Disability insurance

  • ESPP offering

  • Health savings account with company contribution

  • Flexible spending account for either health care and/or dependent care.

  • Family planning benefit

  • Generous parental leave

  • [if applicable] Car allowance

Deciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.


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