Abbott Clinical Research Associate in Scarborough, Maine
DO WORK THAT MATTERS.
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Clinical Research Associate is within our Infectious Disease Developed Markets located at Scarborough, ME. In this role you will support the clinical study execution by participating in the management of domestic and international studies undertaken by Abbott in support of research, marketing/sales and regulatory objectives. This may include management of clinical sample collection studies, reproducibility studies, near cutoff studies, regulatory studies and overall study administration and some study monitoring activities.
Pre-screens, recruits and onboards clinical study sites to include implementation of site screening questionnaires, negotiating clinical study site budgets facilitating contract execution and coordinating IRB submissions.
Manages compliant shipments of biological samples, investigational devices and applicable study supplies.
Manages an inventory of biological samples using a database to track receipt, status, disposition and accountability of samples.
Manages in-house blood draws and internal/external sample collection studies. Maintain compliance with IRB, SOP and applicable regulatory requirements for internal sample collection study administration.
Maintains inventory, track, log and complete final accountability of all supplies and devices shipped and received in support of clinical studies.
Establishes and maintain professional relationships (in person, by phone and/or email) with clinical investigators, study staff, and other Abbott colleagues as necessary to support clinical studies and regulatory submissions.
Initiates, manages and closes out studies with support from clinical management. Performs remote monitoring of study data, and co-monitor external study site data with clinical project team members.
Constructs and audit in-house clinical files and external study site clinical files.
Supports all clinical affairs activities as needed.
Ability to travel up to 30% of the time.
Bachelor’s Degree in Chemistry, Biology, or other related Science field.
3+ years’ experience in clinical study research and/or in biotechnology or related industry
Strong computer skills including knowledge of Microsoft Excel, Word, and Outlook.
Monitoring experience and/or experience with IRB submissions is preferred, but not required.
Strong organizational skills with attention to details.
Excellent oral and written communications.
Strong interpersonal skills and ability to interact at all levels with sensitivity and tact.
Goal oriented and ability to work in a fast paced environment.
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accomodation to qualified individuals with disabilities. To request accomodation, please send an email to MyRecruiter@alere.com.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com