Sr. CTM Associate in Uxbridge

Responsibilities

• Must meet all requirements for Clinical Research Associate position and have demonstrated proficiency in all relevant areas.
• With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
• Assures site compliance with the routine protocol and regulatory requirements and quality of data.
• Assists in the setting and updating of study timelines.
• Assists in CRO or vendor selection.
• With guidance from supervisor coordinates CROs or vendors.
• Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
• Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
• Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
• May participate in abstract presentations, oral presentations and manuscript development.
• Interfaces with individuals in other functional areas to address routine study issues.
• May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
• Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.

Qualifications

• 4+ years of experience and a BS or BA in a relevant scientific discipline.
• 4+ years of experience and an RN (2 or 3 year certificate).
• CCRA or other certification desired.
• Excellent verbal, written, interpersonal and presentation skills are required.
• Working knowledge and experience with Word, PowerPoint and Excel.
• Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Must have a general understanding of functional issues and routine project goals from an organizational perspective.

About Kite Pharma

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA.

Equal Employment Opportunity

Equal Employment Opportunity (EEO) – It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Change The World With Us – Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted. While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.