Senior Clinical Research Coordinator

JOB DESCRIPTION:

About Abbott

At Abbott, we’re committed to helping people live their best possible life through the power of health. For more than 135 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, 113,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott Galway

Abbott in Galway serves as the international hub for Abbott’s Rapid Diagnostics business, which delivers annually more than 2 billion tests. As the global leader in point-of-care diagnostics, Abbott offers the broadest portfolio of best-in-class rapid tests, services, and handheld devices across all healthcare settings: the lab, the clinic, remote healthcare outposts, retail outlets, the patient’s bedside and at home. Our industry-leading near patient tests and services are unmatched across key health and therapeutic areas, including: infectious disease, cardiometabolic & informatics, toxicology and consumer diagnostics.

One of the key functions in Galway is Global Business Services, which provides number of shared services activities across finance, purchasing, quality, technical and customer services for Europe, Middle East and Africa (EMEA). Various global and EMEA commercial and operational management teams across our infectious disease and cardiometabolic businesses are also based in Galway, overseeing the supply of millions of rapid tests from HIV to diabetes to COVID-19, to patients in many regions across the world.

Description

This position works full time in the Abbott Galway office. The Senior Clinical Research Coordinator runs the internal specimen collection protocol for local volunteers. The incumbent is a primary point of contact for contract research organizations conducting sample collections and clinical trials.

Responsibilities and Duties

• Coordinate in-house blood draws and internal sample collection studies. Maintain internal sample study administration in accordance with ethics/IRB requirements, privacy and all applicable regulations.
• Meet and provide direction and progress summaries for contracted vendors collecting samples and conducting clinical trials.
• 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.
• Screen potential study sites, coordinating site questionnaires, and compile 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.
• Prepare and send CDAs, and other study related materials to clinical study sites. Follow up on regulatory approval (IRB/Ethics Committee) status.
• Be familiar with ICH GCP, appropriate regulations, relevant SOP’s and internal tracking systems.
• Be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
• Assist in quality control audits of clinical study documentation (e.g. Trial Master Files, CRF Files, Monitoring Files, etc.).
• Assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
• Copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
• Assist in co-ordination of Investigator payments, if applicable.
• Contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.).
• Assist with distribution, collection, and tracking of regulatory documents for site compliance and audit readiness.
• Identify and resolve routine site issues, protocol deviations, queries, study discrepancies and collects missing or incomplete information.
• Create shipments and complete customs paperwork.
• Co-ordinate document translation, if required.
• Attend project team and department meetings and generate meeting minutes.
• Assist in the production of slides, overheads, etc., as needed for project, departmental, and/or site training presentations.
• Other duties as assigned.

Requirements

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Three years clinical research work experience and Bachelor’s degree (or equivalent).
• ECCRT, ACRP, SOCRA, CCRP or equivalent certification preferred.
• 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%).

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Clinical Affairs / Statistics

DIVISION:

ID Infectious Disease

LOCATION:

Ireland > Galway : Parkmore East Business Park

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie – 37.5Hst0 (Ireland)

TRAVEL:

Yes, 25 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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