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Job #03475

About our client Our Client is a biopharmaceutical company based in Gaithersburg MD. They focus on developing novel genebased therapeutic drugs and vaccines for various cancers. They currently have 3 product candidates in pivotal clinical trials, with a fourth in the pre-clinical phase. Due to tremendous growth at the company, our client is looking for 2-Regional Senior CRA’s to join their team. This is an excellent opportunity for the right candidates to join a fast paced environment! Position Location Sr. CRA Northwest and North Central USA, Homebased Salary Highly competitive package, commensurate with experience Responsibilities 1) Analyzes and evaluates clinical data and ensures compliance with protocol and overall clinical objectives 2) Responsible for implementing, facilitating, and monitoring clinical trials at investigational sites 3) Conducts on-site monitoring visits in accordance with Federal Regulations, Good Clinical Practices, ICH Guidelines and Standard Operating Procedures 4) Establish professional rapport and frequent communication with investigational site personnel and document with appropriate forms and monitoring reports 5) Educate the investigational sites in all regulatory procedures, protocol interpretations, documentation requirements, and data clarification 6) Ensure accurate documentation and completion of all follow up information on serious adverse events identified 7) Understand, implement, facilitate and maintain project timelines and seek assistance from other team members when appropriate 8) Proactively works to identify, address, resolve and communicate all ongoing investigational site issues in conjunction with the project team 9) Demonstrate, understand and comply with SOPs and ICH/GCP Standards 10) Manage and monitors Initiation, Interim, and Closeout study visits 11) Participate in the recruitment of sites 12) Participate in the development of study related tools Requirements 1) Requires a Bachelors/Masters degree in a scientific discipline or equivalent 2) Knowledge of U.S. Drug Development process and monitoring practices; knowledge of FDA regulations/ICH strongly preferred 3) Must have demonstrated knowledge of industry standards in managing multiple clinical data for studies in pre-approval phases 4) Minimum 2-5 years experience monitoring oncology studies required 5) Nursing License or ACRP or SOCRA CRC certification preferred 6) Excellent verbal, written, and presentation skills as well as computer proficiency 7) Proficiency in Microsoft Office (MS Word, Excel, PowerPoint, etc.) 8) Solid experience with EDC studies, prefer experience with InForm. 9) Ability to anticipate training needs of clinical sites and plan for their success 10) Ability to consistently meet required due dates for visit documentation (reports and letters) per study Clinical Management Plan 11) Ability to function well as part of the study team 12) Ability to effectively represent the company at clinical sites