Senior Clinical Research Specialist - Nutrition - Columbus, OH

$64,000 - $128,000/Yr

Abbott Laboratories - Columbus, OH

Full-time - Mid Level

Onsite - Columbus, OH

10,001+ employees

Miscellaneous Manufacturing

About the position

The Senior Clinical Research Specialist at Abbott plays a crucial role in managing the execution of high-priority clinical trials within the Nutrition Division. This position involves overseeing the entire lifecycle of clinical studies, ensuring compliance with regulations, and collaborating with cross-functional teams to achieve business objectives. The specialist will also represent Abbott in audits and engage with external stakeholders, contributing to the development of innovative nutrition products that enhance health outcomes.

Responsibilities

• Manage the overall execution of Research Services aspects of assigned clinical trials from protocol development to closeout.
• Collaborate with cross-functional study team members to meet business objectives and timelines.
• Ensure compliance with Abbott policies and regulations for assigned projects.
• Represent the functional area in internal and external audits of assigned studies.
• Participate in department activities related to best practice research standards and Good Clinical Practice (GCP).
• Review protocols and Case Report Forms (CRFs) during development and contribute to enrollment procedures.
• Enter study activity in the eTMF and Clinical Trial Management System for document tracking.
• Review product accountability records and resolve issues with study sites.
• Initiate timely payments to study sites and communicate with Clinical Planning/Finance.
• Perform randomization, product accountability, and supply reconciliation for studies.
• Manage Investigator Sponsored Studies (ISS) throughout their lifecycle, including submission and approval processes.
• Educate internal stakeholders on ISS processes and ensure compliance with requirements.

Requirements

• BA in health profession or scientific related field preferred.
• 5+ years' experience in the clinical research industry preferred.
• Excellent written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Ability to work well under pressure and take initiative on unfamiliar tasks.
• Basic and advanced computer skills, including word processing and spreadsheets.
• Experience with Clinical Systems including eTMF, CTMS, and Payments.

Nice-to-haves

• Understanding of Good Clinical Practice and research industry standards preferred.
• Proficiency with clinical systems and/or experience with clinical trial management systems preferred.

Benefits

• Career development opportunities within an international company.
• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan after qualifying.
• Excellent retirement savings plan with high employer contribution.
• Tuition reimbursement and student debt programs.
• Recognition as a great place to work and for diversity.