Sr./Clinical Trial Associate - Clinical Operations

Aktis Oncology; Boston (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Aktis Oncology, Inc. is seeking a Clinical Trial Associate/Sr. Clinical Trial Associate to support planning, execution and documentation of radiopharmaceutical trials.

You will work under the Senior Director, Clinical Operations, coordinating with sites, vendors, and cross-functional teams to ensure quality and compliance. This role will drive key activities from study startup to close-out, including document development and review, site initiation packets, ethics approvals, and ongoing study

Qualifications

• Bachelor's degree or equivalent in life sciences, healthcare, or related field.
• 1–3 years of clinical research experience, preferably in pharma/biotech/CRO.
• Oncology experience preferred for this role.
• Strong knowledge of ICH-GCP guidelines and CFR.
• Operational knowledge in clinical research, with CRO/vendor oversight.
• Experience interacting with global or regional teams in a virtual environment.
• Familiarity with eTMF, CTMS, or EDC is a plus.
• Attention to detail, decision-making and communication are essential.
• Willingness to travel 10–20% for site visits and conferences.

Responsibilities

• Support planning, execution and documentation of clinical trials with radiopharmaceuticals.
• Assist study startup, tracking, document management and external vendor coordination.
• Coordinate with CROs, vendors and clinical sites for day-to-day trial activities.
• Contribute to study status reports and metrics for internal stakeholders.
• Perform QC checks of study documentation and eTMF; assist audit prep and closure.
• Maintain inspection readiness throughout day-to-day activities.

Skills

ICH-GCP knowledge

Cross-functional collaboration

Project management

Global team coordination

Attention to detail

Communication skills

Travel readiness

Clinical operations knowledge

Education

Bachelor's degree or equivalent in life sciences

Tools

eTMF

CTMS

EDC

Job description

Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. Aktis' most advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis' second pipeline program, AKY-2519, is a miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung and other solid tumors. Aktis has a strategic collaboration with Eli Lilly and Company to leverage its miniprotein platform to develop novel radioconjugates outside of Aktis' proprietary pipeline.

Aktis Oncology is seeking a Clinical Trial Associate/Sr. Clinical Trial Associate. This role will report to the Senior Director, Clinical Operations.

RESPONSIBILITIES

The Clinical Trial Associate (CTA) will support the planning, execution, and documentation of clinical trials involving radiopharmaceutical agents. Working under the direction of the Clinical Trial Manager or Clinical Operations Lead, the CTA will assist with key trial activities including study start-up, tracking, document management, and coordination with external vendors and clinical sites. This role is critical for maintaining quality, compliance, and operational efficiency across clinical programs.

This role will drive several areas of strategic importance to Aktis:

• Support day-to-day operations of clinical trial conduct
• Organize/maintain tracking systems and set up metrics and tools to support the conduct of a clinical study from start-up to close-out, including enrollment, monitoring visits, essential documents, etc.
• Assist with the development and review of clinical documents including protocols, ICFs and clinical study plans
• Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
• Assist in the creation, collection, and review of essential regulatory and study documents (e.g., site initiation packets, investigator CVs, ethics approvals).
• Coordinate and communicate with CROs, vendors, and clinical sites to support day-to-day trial activities.
• Support the compilation of study status reports and metrics for internal stakeholders.
• Perform ongoing QC checks of study documentation and eTMF.
• Assist in audit preparation and resolution of audit findings.
• Ensure inspection-readiness at all times during day-to-day activities.

QUALIFICATIONS

• Bachelor’s degree or equivalent, in life sciences, healthcare, or related field.
• Minimum of 1-3 years of clinical research experience, preferably in the pharmaceutical, biotech and/or CRO industry.
• Oncology therapeutic area experience is preferred for this position.
• Strong knowledge of ICH-GCP guidelines and Code of Federal Regulations.
• Requires clinical research operational knowledge, computer literacy, and strong project planning/management including oversight of CROs/vendors.
• Experience and ability to interact with global or regional teams in a virtual environment.
• Familiarity with clinical trial systems such as eTMF, CTMS, or EDC is a plus.
• Strong attention to detail, decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
• Willingness to travel up to 10-20% of time (eg site visits, conferences, etc).
• Strong desire to be part of a patient-centric company.
• Proven demonstration of transparent communication and fostering open and diverse debate.
• Ability to work with agility and manage ambiguity.

Aktis Oncology is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Aktis Oncology is committed to promoting and maintaining a work environment in which all applicants, employees, and other individuals are treated with dignity and respect, free from unlawful harassment, discrimination, or retaliation.