What are the responsibilities and job description for the Clinical Trial Associate position at Ardelyx?
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Position Summary:
The Clinical Trial Associate (CTA) will work with the senior members of the Clinical Trial Management team to conduct all assigned activities in an efficient and effective manner in support of the overall study timelines and to help ensure all deliverables meet the team and corporate objectives.
Responsibilities:
- Handle responsibilities in all operational aspects of the assigned clinical trial(s) from study start-up to close-out
- Develop and maintain study-related trackers such as protocol deviation, adverse events and training trackers
- Ensure study trackers are accurate and kept up to date, including those related to protocol deviations, adverse events, and site personnel training
- Perform data verification to ensure data accuracy in different trackers against EDC and other systems
- Handle various assigned duties related to clinical studies such as facilitating document reviews, routing materials for training, and monitoring progress
- Author, update, format and route documents, training material, study related plan and templates for review and finalization
- Follow-up on outstanding action items until resolution
- Author and maintain agenda, minutes, and status updates, as applicable
- Review and upload documents to eTMF, QC, filing and reconciliation in accordance with regulatory guidance and internal SOPs
- Follow SOPs and work instructions and effectively identify when deviations from procedures and implement
- Conduct CTMS and other systems validation to ensure accuracy and compliance, if needed
Qualifications:
- Bachelor’s degree in relevant scientific discipline with 2 years of experience in Clinical operations or healthcare-related experience or equivalent experience
- Good understanding of the various stages of clinical trials, from protocol design through to study completion
- Ability to work independently on routine assignments or under supervision on new assignments
- Proficiency with Microsoft applications (e.g., Microsoft Word, Excel, PowerPoint, Outlook)
- Working knowledge of clinical protocols and ICH/GCP regulations
- Effective organizational skills, ability to manage multiple tasks and attention to detail
- Excellent teamwork and collaboration skills
- Excellent oral and written communication skills
- Knowledge and Understanding of Smartsheet is a plus
- Travel may be required
The anticipated annualized base pay range for this full-time position is $85,000-$103,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Salary : $85,000 - $103,000
