Clinical Research Coordinator

Abbott Laboratories hiring for Clinical Research Coordinator jobs in South Portland, ME, US

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of .
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our South Portland, Maine location in the Rapid Diagnostics, Infectious Disease division. Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

What You’ll Work On

• Coordinate the generation, receipt and filing of required study documentation, including but not limited to study logs, study binders, and regulatory documents according to applicable SOPs.
• Assist with screening potential study sites, coordinating site questionnaires, and compiling site data for review by the clinical study lead or designee.
• Inventory the receipt of biological samples and populate a database to track the disposition of samples.
• Coordinate in-house blood draws and internal sample collection studies. Maintain internal sample study administration in accordance with IRB requirements, HIPAA privacy and all applicable regulations.
• Prepare and send CDAs, and other study related materials to clinical study sites. Follow up on regulatory approval (IRB/Ethics Committee) status.
• To be familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems.
• To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
• To assist in quality control audits of clinical study documentation (e.g. Trial Master Files, CRF Files, Monitoring Files, etc.).
• To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
• To copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
• To assist in co-ordination of Investigator payments, if applicable.
• To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
• To co-ordinate document translation, if required.
• To attend project team and department meetings and generate meeting minutes.
• To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
• To assist in the production of slides, overheads, etc., as needed for project, departmental, and/or site training presentations.
• Other duties as assigned

Required Qualifications

• Three years clinical research work experience and
• Bachelor’s degree
• Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
• Good written and verbal communication skills.
• Good written and spoken English.
• Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.
• Willingness to travel for job related activities if required (expected travel for this position is < 30%).

Preferred Qualifications

• Experience with Veeva

The base pay for this position is $26.30 – $52.60 per hour. In specific locations, the pay range may vary from the range posted.