General Job Description/Team Overview:
The Senior CRA is an integral part of the Clinical Operations team and is responsible for the oversight and execution of company-sponsored clinical trials, ensuring expectations for recruitment, data management, and operational efficiency are met and exceeded. The Senior CRA is charged with ensuring all clinical projects are conducted in accordance with local, federal, state, and institutional regulatory policies and are delivered on time and within budget.
Primary Duties and Responsibilities (include but are not limited to):
● Governs and operationally manages the clinical project team.
● Coordinates clinical projects including tasks from design input through clinical study report completion.
● Collaborates with the Assistant Director, Clinical Operations, Chief Medical Officer, and other contributing company members on the development of central trial documents including Protocols, Investigator Brochures (IBs), Study Reference Manuals (SRMs), Informed Consent Forms (ICFs), Electronic Data Capture (EDC) systems, Clinical Monitoring Plan, and other study management plans.
● Achieves study objectives by working with vendors and team members to set project priorities and milestones and solve project challenges.
● Assists in presentation of quarterly clinical trial updates to the executive team and key stakeholders.
● Assesses the operational feasibility of studies and recommends execution and risk mitigation plans.
● Develops and manages study timelines, budget, and quality metrics.
● Ensures appropriate clinical resources are available for the clinical project.
● Monitors study activities to ensure compliance with protocols, company SOPs and that GCP and regulatory requirements are maintained; including compliance with all relevant local, federal, and state regulatory and institutional policies.
● Participates in CRO and other vendor selection, negotiation, and management, including monitoring of associated budgets and payments. Oversees CRO and vendor activities and documents.
● Partner with the cross-functional team (e.g., clinical data management, vendor teams) for data reviews, query management, and resolution.
● Proactively identifies and resolves issues; initiates process improvement initiatives when needed.
● Reviews monitoring and audit reports to confirm appropriate conclusions and actions taken.
● Reviews Serious Adverse Events and other pertinent data with the Chief Medical Officer, medical monitor, and drug safety personnel to identify safety trends and potential risks.
● Performs other duties as necessary for project completion.
● 5+ years of clinical research experience in an industry-sponsored setting.
● Bachelor’s and/or Master’s degree in Life Sciences, Nursing, Pharmacy, or equivalent.
● Thorough knowledge of ICH GCP guidelines HIPAA, the Protection of Human Research Subjects, CFR regulations for recruitment and consent of research subjects, and other regulatory requirements for clinical trial management. General knowledge of Federal and State regulatory requirements in GMP and GLP environments.
● Solid understanding of FDA and other regulatory requirements that may impact global clinical studies.
● Familiarity with global Phase I & II clinical trials; gene & cell immunotherapy trial experience strongly preferred. Therapeutic experience in oncology is desirable.
● Excellent organizational, leadership, and problem-solving skills, with attention to detail and accurate record keeping
● Outstanding work ethic and strong personal discipline.
● Experience participating in cross-functional teams to meet goals and metrics.
● Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.
● High degree of discretion dealing with confidential information.
● Ability and willingness to work flexible hours when needed.
● Demonstrated ability to work independently and in a team environment.
● Excellent written, verbal, and interpersonal communication skills.
● Eligible to work in the U.S.
Job Type: Full-time
If you're interested in joining our Team, start by applying here and attaching your resume.