Senior Clinical Research Coordinator

3 weeks ago

South Portland, United States Abbott Laboratories Full time

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 114,000 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

Our Rapid and Molecular Diagnostics division currently has an opportunity for clinical research coordinator in South Portland, Maine.

The Clinical Research Coordinator supports clinical study activities by assisting with domestic and international studies undertaken by Abbott in support of research and development. This may include the coordination of clinical studies, support for Veeva CTMS, eTMF, studies invoices tracking, clinical documentation maintenance, and shipping of required study supplies and management of internal biological sample inventories.

What You'll Work On:

* Provide business administrative support for clinical studies and sites management in Veeva CTMS. Support study teams for filing study documents in TMF. Create studies, sites and site personnel in Veeva, support team access to different studies, help troubleshoot and provide support for training.
* Assist in the filing of required study documentation, including but not limited to study logs, study binders, and regulatory documents according to applicable SOPs.
* Support tracking of studies and sites level budget, purchase orders and invoices. Assist with creating a new vendor in the procurement system.
* Coordinate compliant shipments of biological samples, investigational devices and other applicable study supplies.
* Inventory, ship, track and log all supplies and devices in support of clinical studies. Facilitate final accountability of all clinical supplies and devices.
* 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.
* Maintain clinical study activities in spreadsheet templates, consistent with company timelines and objectives.
* Construct in-house and study site clinical files.
* Support all clinical affairs activities as needed.

Required Qualifications:

* Strong organizational and interpersonal skills required.
* PowerPoint, Excel, Word and other computer skills necessary.
* BA/BS (chemistry, biology or other science preferred) and 1-3 years' experience in clinical study support and/or in biotechnology or related industry preferred.

Preferred Qualifications

* Previous experience with Veeva CTMS and TMF is preferred

The base pay for this position is $31.55 - $63.15 per hour. In specific locations, the pay range may vary from the range posted.

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