Senior Clinical Research Associate

Senior Clinical Research Associate Our client is an aggressively growing biopharmaceutical company based in California.  They have asked us to assist them in their search for a Senior Clinical Research Associate. The position chosen for this role 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 include: 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). Add 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. 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. Actively design vendor budget and payment reconciliation processes (e.g. reviews contracts, tracks payments in association with agreed-upon budget, etc.)  We seek candidates with the following qualifications:  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. BA/BS degree in life sciences and 4 years of experience as a CRA, including a minimum 2 years working in a leadership role on Sponsor side and minimum of 2 years monitoring. Previous experience in cardiovascular therapeutics preferred. Experience in international trials and Phase I-III cardiovascular research studies preferred. 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%) Do you have the skills and experience we seek and want to advance your career with a pioneering company?  If so, please email your resume as a Word attachment to kim@fcgsearch.com , reference code 2268-M.  No calls or faxes, please.  Include your daytime phone number and we will contact you confidentially or reply to your email.  Fairway Consulting Group is a leading executive search firm dedicated to the pharmaceutical and biotechnology industries.  www.fairwayconsultinggroup.com or www.fcgsearch.com MRINetwork, one of the world's largest search and recruitment organizations, has over 1,000 offices in more than 35 countries. Each office is a single point of contact that allows candidates to access high-quality positions virtually anywhere in the world. MRINetwork recruiters are industry specialists who typically have real-world experience in the industries they serve. LOCATION: Job location not provided JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: 2268-M COMPANY: Fairway Consulting Group ADDRESS: 300 Merrick Road - Suite 404Lynbrook,NY 11563 PHONE: 516 596-2800 EMAIL: Apply by Email