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Senior Clinical Research Associate

Company: Aerotek
Location: Reading
Posted on: February 25, 2021

Job Description:

Description:ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:Independently manage all phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools. Conducts Qualification, Site Initiation, Interim, and Close-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations. Train site personnel regarding the protocol and applicable regulatory requirements.Ensure each site is meeting its goals of follow-up rate, data clean deadlines, protocol compliance, and enrollment.Lead study meetings to ensure completion of established project team goals and objectives, including study training and data review. Facilitate corrective action assessment and maintain TMF in BIMO readiness. Provide study status updates to Management team and develop sufficient resolution of identified action items. Contribute to annual reports, data management, data analysis, and publication support. Develop and assesses SOPs annually, as needed. Maintain current knowledge of applicable US and international clinical regulations and guidance documents. Participate in department systems and development initiatives including related trainings. Support investigator meetings as needed. Support Protocol Deviation and Adverse Event review and reporting. Maintain credentialing requirements at hospitals and clinics as needed. Complete projects and tasks consistent with corporate objectives. Support the Clinical Operations team in general and with various improvement projects. Perform other duties as assigned. Contribute to the company culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun.Additional Skills & Qualifications:QUALIFICATIONS, ESSENTIAL SKILLS AND ABILITIES:BS in Science degree preferably in natural sciences or related field, or related practical experience. At least 7 years of clinical research experience, medical device experience preferred. US IDE, IND, and OUS experience desirable. Ability to foresee and prevent risks and understand when to elevate issues to management and recommend corrective action. Excellent time management skills. Ability to recognize potential obstacles and develop solutions to resolve them with minimal consequence within set timelines or change direction if priorities are modified. Ability to make critical, independent decisions and be accountable for actions within a fast-moving environment. Ability to perform at high-level with limited supervision and effectively partner with team members when necessary. Ability to exercise critical thinking skills in selecting methods, techniques, and evaluation criteria. Proficient in Microsoft Word and Excel, and the ability to quickly learn other software tools and applications, such as Access, etc. Ability to develop strong relationships with investigative sites. Ability to travel approximately 20-75% to attend meetings, perform training and monitoring.Experience Level:Expert Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Reading , Senior Clinical Research Associate, Other , Reading, Pennsylvania

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