Scios Inc., a Johnson & Johnson company, is a biopharmaceutical company headquartered in Fremont, California. Scios is developing novel treatments for cardiovascular disease, inflammatory disease and cancer. The Company's disease-based technology platform integrates expertise in protein biology with computational and medicinal chemistry to identify novel targets and rationally design small molecule compounds and peptides for markets with unmet medical needs. For more information, visit www.sciosinc.com.
Description:
Candidate will support Clinical Research Manager with the operational activities related to the planning, implementation, and reporting of clinical research studies in accordance with ICH/GCP guidelines and all applicable Scios and Johnson and Johnson standard operating procedures (SOPs). Will support on some aspect of CRO and Vendor management including relationship and training. Provide guidance and direction to in-house and contract / CRO CRAs in learning study procedures and requirements. Assist in study planning, set-up, and reporting of the Clinical Trials. Contribute to the design, content, and preparation of clinical protocols, amendments, informed consent forms and other study related documents / tools. Identifying issues, possible resolutions to issues and communicating the results. Position will require collaboration with CRO to identify enrollment barriers and provide solutions, resolve patient eligibility questions and work with the clinical research manager and CRO to develop recruitment strategies. Must maintain regular contact with CRO and all relevant internal departments such as regulatory affairs, drug safety, and others as necessary. Prepare and communicate study updates to Study Manager and other study staff. Conduct periodic co-monitoring visits with CRO to assure regulatory compliance of investigational sites with company SOPs and ICH/GCP guidelines. Ensure successful implementation of the clinical studies in accordance with ICH/GCP guidelines and all applicable Scios and Johnson and Johnson SOPs.
Requirements:
The successful candidate will have BS preferably in a scientific discipline, or health-related field; Five or more years of clinical monitoring experience as a CRA in a pharmaceutical / biotechnology company or CRO; experience in Phases II and III of drug development.
Skills required: demonstrate working knowledge of ICH/GCP guidelines, and FDA regulations; experience with working with CROs; be able to work independently and efficiently; demonstrated problem-solving abilities in overseeing clinical studies with tactfulness and diplomacy in dealing with internal and external study staff; Excellent oral and written communication skills and organizational abilities; ability to resolve issues independently; be able to work independently and efficiently; basic computer literacy (e.g. MS Word, Excel, PowerPoint); experience with EDC highly desirable.
Desired experience in cardiovascular therapeutic area (preferred) and in a leadership role (beyond monitoring and basic site management) strongly preferred. CCRA certificate or equivalent is desirable.
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