Clinical Trial Associate

The Alliance for Clinical Trials in Oncology Foundation (Foundation) is a foundation created to enhance and expand the ability of the Alliance for Clinical Trials in Oncology (Alliance) to conduct cancer clinical research and address important treatment questions through large-scale clinical trials. Through efforts of the Foundation in support of the Alliance, clinical trials and laboratory research are conducted to discover new or improved ways to prevent, treat, and cure many types of cancer, including leukemia and lymphoma, and cancers of the breast, prostate, lung, and gastrointestinal (GI) tract, and help educate the medical community on methods of cancer diagnosis, treatment, and prevention.

The Alliance for Clinical Trials in Oncology Foundation is looking for a Clinical Trial Associate who is excited to support the Pharmaceutical Collaborations Team and cross-departmental collaboration needs for Alliance NCTN trials. The CTA’s involvement includes (but is not limited to) supporting trial development needs, CRO vendor oversight, site management, project management, and program management. We are an organization of passionate, team-oriented professionals driven to change the face of cancer.

Benefits of working at the Alliance for Clinical Trials in Oncology Foundation:

● 8 weeks of paid time off (including PTO, sick, and holidays) during year one

● Medical, Dental & Vision plans with 100% employer-paid option for employees

● Tuition reimbursement stipends

● Continuing Education

● 3% employer match for retirement investments

● Annual Employee Performance Bonus Program

● Annual Cost of Living Adjustment

● 50% commuter reimbursement

● Healthy Work/Life balance and flexibility

Requirements

ROLE & RESPONSIBILITIES

Assist in preparing, organizing, and maintaining documents such as for the program or for a specific trial

Ensuring appropriate filing/storing of study-documents, in accordance with FDA Code of Federal Regulation (CFR), International Conference of Harmonization (ICH), Good Clinical Practice guidelines and Alliance policies and procedures

Maintain oversight of signature routing, in accordance with CFR/ICH/GCP guidelines, for finalizing study document

Tracking study documents/materials for oversight of engagement with pharmaceutical partners

Identifying and tracking deviations from study plans, in accordance with CFR, ICH, and GCP guidelines

Support site engagement by executing established plans, such as for site staff training

Support accrual enhancement by providing oversight and implementing established study-specific plans

Track significant trial events, such as for issues that arise and the associated resolution

Assist with the creation of start-up plans and templates

Accurately enter and manage activity within project management systems/plans

Facilitate communication with site monitoring CROs

Engage in site management and trial management by overseeing study-specific mailboxes

Work closely with Project Coordinator, Project Manager, Clinical Study Manager, Director of Industry Collaborations & Trial Management

Oversee adherence to study-specific monitoring requirements such as monitoring visit timelines or monitoring reports occurring within the required time frame

Support monitoring needs by supporting oversight of the quantity of data review needs

Cross-collaboration with internal departments/teams such as Budgets, Contracts, Protocol, Quality, Statistics and Data management, Executive/Senior Leadership, etc

Other related duties as assigned to meet program and organizational objectives

QUALIFICATIONS & EDUCATION REQUIREMENTS

A minimum of BA/BS degree is required

Degree in a health or life science major preferred

1-2 years of relevant experience in biotech, pharma, and/or CRO or 2-4 years of relevant project management experience required

Working knowledge of ICH/GCP/CFR guidelines required

Demonstrated project management skills preferred

Proficiency in Microsoft Office Suite required

Strong organizational skills and ability to prioritize workload to meet tight deadlines in a dynamic work environment

Strong interpersonal, written, and verbal communication skills required

Ability to effectively work within a team and independently required

Flexibility and adaptability to workplace environment undergoing change management to support scaling of business required

Permanent