Study Associate II, 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 unwavering 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 in drug development. The role and contributions of our Study Associates are instrumental to our study teams' success. 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 II is accountable for the performance and compliance of an assigned protocol and sites. The incumbent supports Clinical Operations with the internal operational management of clinical studies, providing support for the planning, coordination, monitoring, tracking and general performance of clinical studies. A critical component of the position is providing support to the study team and/or lead specific operational activities, assisting with study start up activities such as feasibility, site selection, co-monitoring, site communications and other related study documentation and management activities. In collaboration with the study manager, providing oversight of the contract research organization and other vendors performance to ensure quality and study timelines are maintained. The Study Associate II may lead a study of limited scope and complexity.

Performance Objectives:

• Guides study site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability in partnership with CRO.
• 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 track related trends.
• Tracks monitoring related issues, risks, or findings with Investigators/site staff, and escalates to the Study Manager and/or CRO as needed.
• Attends co-monitoring visits as required per the CRO Oversight Plan, or as needed by Sponsor.
• Participates and provides input to study start-up activities including feasibility, site budget/contract review, Investigator Meetings, enrollment planning, and Investigator selection.
• Leads or supports study TMF by reviewing the TMF plan, oversees TMF set-up, study team training, periodic quality review, and document management. Reviews and maintains TMF documents, including documents related to IP release. Collaborates with team members on TMF related key performance indicators.
• Collaborates closely with study management, CRO study managers, and CRO monitoring staff, in reviewing site/patient activity tracking and preparing study updates. May support the oversight of the CRO/vendor to ensure outsourced activities are executed according to the contract and with high quality. Provides updates to the study team on the progress of CRO/vendor's activities.
• Identifies and resolves clinical study conduct issues and ensures site compliance with Good Clinical Practice, and federal and applicable local regulatory requirements through regular communication with Investigators/site staff.
• Monitors the study progress to ensure compliance with and adherence to the project plan and to identify, evaluate and resolve problems.
• Works with internal and external functional teams to ensure accountability of all used and unused IMP. Maintains drug and sample accountability trackers, as needed.
• Facilitates study close-out activities.
• Reviews and provides input to study plans and guidelines, including study monitoring plans.
• Collaborates with study management in the development of study documents, such as informed consent forms, study logs, and study manuals.
• Provides support across all study phases, including but not limited to vendor set-up, enrollment, site-related documentation, and inspection readiness. In some instances, may lead a vendor for oversight.
• Collaborates closely with study manager to align expectations and study priorities on ongoing basis.
• Communicates deviations from the protocol, GCP, and the applicable regulatory requirements to internal management and the investigator as applicable.
• Manages access to internal study systems for applicable internal and external study team members.
• May be responsible for overseeing study management activities, including CRO oversight, directly managing a smaller and less complex study or study during the extension phase or close out activities. If delegated these tasks, Study Associate III will be supported by the clinical operations compound lead.
• Updates internal study trackers/dashboards with accurate enrollment and other study information.
• Coordinates cross functional study team meetings and supports study manager with meeting minutes for assigned studies.

Education/Certification Requirements:

• Bachelors' degree in a relevant scientific discipline is preferred, or an equivalent combination of education/experience in science or health-related field required.

Knowledge, Skills, and Abilities:

• 3-5 years of relevant clinical trial support and site management experience in the pharmaceutical, biotechnology, CRO and/or healthcare industry.
• 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 Phase I-IV clinical trials.
• Has demonstrated knowledge of, and competence in, application of FDA/GCPIICH 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 pay range for this position at commencement of employment is expected to be between $95,200 - $112k 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.

#LI-Hybrid #Location-Princeton,NJ 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.