Study Associate I, Clinical Operations

Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our "People first" approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.


Hybrid


Employee Value Proposition:


At Taiho Oncology, our dedication to patients drives us to work collaboratively across various functions to achieve impactful results. The leadership and support provided by our Clinical Operations team are the cornerstone of our success and the purpose and contributions of our Study Associates are instrumental to our study teams. The Study Associates efforts directly contribute to the success of our trials and, ultimately, to the betterment of patient outcomes. This position offers an exciting opportunity to be a part of a dynamic team cultivating growth and learning.


Position Summary:


The Study Associate (SA) I is responsible for operational study support during study start-up, maintenance, and close-out. The SA I helps with the coordination of project activities, including corresponding with internal and external team members globally, assisting, updating of study trackers and systems and overseeing study documentation and Trial Master File. The SA supports the Clinical Operations department with developing processes and procedures and sharing lessons learned.


Performance Objectives:

• Coordinates cross functional study team meetings and supports study manager with meeting minutes for assigned studies.
• Updates internal study trackers, dashboards, and systems with accurate study information (enrollment, study systems and tools/trackers, study team contact list, etc.).
• Responsible for the review of the TMF plans to ensure consistency across studies and alignment with internal TMF procedures.
• Monitors Trial Master File related KPIs and performs quality review of the eTMF (per CRO oversight plan) while collaborating with internal and CRO study teams to resolve any issues and risks.
• Reviews Monitoring Visit Reports (SEV, SIV, IMV, COV) from the CRO to ensure that sites are in compliance with the study and protocol. Reviews monitoring and other study operation plans and tracks related trends and KPIs.
• Provides support across all study phases, including but not limited to vendor set-up, enrollment, site-related documentation, and inspection readiness.
• Collaborates closely with study manager to align expectations and study priorities for support.
• Manages access to internal study systems for applicable internal and external study team members.
• Assists with the onboarding of new hires, when applicable regarding system access or internal processes.
• May review and approved site level informed consents as compared to the master informed consent.
• Reviews and approves site budgets and escalates any issues to the study manager.
• Reviews and approves essential documents (green light) for drug release.
• Proactively incorporates learning and recommendations from other teams and practices and promotes standardization and efficiency in operations practices and processes ensuring consistent delivery across studies.

Education/Certification Requirements:

• Associate's degree or equivalent. Bachelors' degree in biological sciences is preferred.

Knowledge, Skills, and Abilities:

• 2 years of relevant clinical trial support or site management experience in the pharmaceutical, biotechnology, CRO and/or healthcare industry.
• Experience and knowledge of Trial Master File and essential documents.
• Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct clinical trials.
• Has demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines.
• Attention to details and well-organized.
• Solution oriented and exceptional collaboration skills.
• Must possess the ability to multi-task and effectively prioritize in order to ensure clinical trial goals.
• Recognize potential obstacles and work to resolve them within set timelines.
• Delivers work conscientiously and precisely even when under pressure.
• A team player and able to work in a dynamic environment with attention to high quality results.
• Excellent communication skills both verbal and written.
• Good proofreading skills.
• Takes initiative and utilizes good judgment.
• Ability to effectively present information and respond to questions internally and externally.
• Ability to collect information; define problems, establish facts, draw conclusions and propose feasible actions.
• Prepares PowerPoint slide decks and other presentation materials for a variety of internal and external presentations and training.
• The incumbent in this position may be required to perform other duties, as assigned.

The pay range for this position at commencement of employment is expected to be between $73,100 - $86,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.

If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.


#Location-Princeton,NJ #LI-Hybrid Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email [email protected] . Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties, as assigned.