Senior Clinical Research Associate

Job Description:Position reporting to Clinical Operations Manager/ Director, the Senior Clinical Research Associate (Sr. CRA) will perform clinical research duties that include leadership in the following areas: protocol development and writing, planning, study implementation and execution, conduct/oversight, clinical study monitoring and management, study budgets, CRO/vendor management and reporting. The candidate in this position may act as the Lead CRA/Clinical Project Manager on studies with moderate to high number of sites.Major Responsibilities/Accountabilities: Essential functional duties of the position. Independently manage various activities. Associated with multiple clinical studies in accordance with designated project assignments. Oversee clinical trial progress and ensure compliance with SOPs and regulatory requirements (CRF/ICH GCP. Identify, evaluate, select, and manage CROs, contractors, and other vendors (IVRS, eCRF, monitoring, clinical drug storage/distribution centers, central/specialty laboratories, etc). Adds critical insight regarding vendor selection process as required. Serve as primary contact for vendors. Participate in the design and development of clinical protocols and case report forms. Write clinical protocols, amendments; informed consent forms, monitoring plans, site study manuals, and related study documentation. Prepare study budgets and timelines. Manage site and vendor budget and contract negotiation. Coordinate efforts in study start up through closeout activities, including: study feasibility, site selection, preparation and follow-up of site regulatory packages. Coordinate and conduct CRA and site training of protocol and operational requirements. Ensure consistency in instructions to investigators and their personnel for compliance with protocol and regulatory requirements. Oversight and review of monitoring reports as needed. Manage key study parameters (study start-up activities, drug preparation, enrollment, data collection, etc) and proactively identify solutions within the study team when issues arise. Create and implement project tools, tracking tools, etc. to report study specific metrics. Prepare progress updates. Manage all study supply requirements (storage, distribution, site inventory, etc). Assist with the projection and management of clinical supply inventory. Performs independent monitoring of sites as required by needs of project. Assist in the review of clinical study reports. Use well-developed problem-solving skills to address needs of program. Other responsibilities/accountabilities: (marginal functions) Takes initiative to address cross-departmental issues that affect the clinical trial to which he/she is assigned. Support of departmental functions such as preparation for and attendance at departmental meetings, project team meetings, clinical operations training and developmental activities as required and directed.Relevant Quantitative Dimensions (e.g. budget, supervisory responsibilities). Actively designs vendor budget and payment reconciliation processes (e.g. reviews contracts, tracks payments in association with agreed-upon budget, etc.)

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Job Experience:Knowledge/Skill Requirements: All CRA skills, plus: demonstrated skill in study budget development and financial management, conscientious resource management, aptitude for training both in-house and site personnel, ability to work in cross-functional environment. Normally requires no instruction on routine work; general instructions on new assignments. Able to resolve routine issues independently. Must have demonstrated problem-solving abilities in overseeing clinical studies, and demonstrate tactfulness and diplomacy in dealing with internal and external team members. Advanced computer literacy required (eg. MS Word, Excel, PowerPoint). Must have excellent oral and written communication skills and strong organizational abilities. Must be able to work efficiently independently or in a team environment. Must be able to manage multiple tasks, priorities, and timelines. Ability to travel important (20%), previous experience In cardiovascular therapeutics preferred. Experience in international trials and Phase I-III cardiovascular research studies preferred. Bachelors degree in life sciences and 4 years experience as a CRA, including a minimum 2 years working in a leadership role on Sponsor side and minimum of 2 years monitoring. CV Therapeutics, Inc., headquartered in Palo Alto, CA, is a Biopharmaceutical company focused on applying molecular cardiology to the discovery, development and commercialization of novel, small molecule drugs for the treatment of cardiovascular diseases, the leading cause of death in the United States.CVT offers competitive salaries and an excellent benefits package, including stock options and an employee stock purchase plan. To apply for this position, please go to https://www.cvt.apply2jobs.com Equal Opportunity Employer.Minimum Education Required: BachelorYears of Experience Required: 3-5 YearsExpected Travel Time: About 25%