Sr. Clinical Research Specialist

Sr. Clinical Research Specialist

Long term remote contract

Responsibilities may include the following:

• Review and reconcile the study trial master file as planned with the study team
• Support team with FDA BIMO audit preparations
• Support study team activities to increase site compliance, data quality, and data analysis and reporting
• Ensure sites are conducting activities per their protocol, local IRB requirements, and executed contract.
• Frequent communication with the study lead on site status updates as well as internal leadership.
• Manage clinical study sites by frequent communication with sites to ensure they have the proper documentation and training to begin enrolling subjects, as well as ensure sites are maintaining compliance by enrolling, submitting data, resolving queries, and resolving action items.

Requirements:

• 4+ years of Clinical Research experience in medical device industry.
• Degree in engineering, life sciences, or related medical/scientific field.
• Proficient knowledge in medical terminology.
• Proficient knowledge in MS Office Productivity Tools
• Knowledge of ICH-GCP guidelines
• Knowledge of IRB and FDA compliance
• Knowledge of 21CFR 812 Source Data Verification
• CCRA certification (Certified Clinical Research Association), ACRP, CCRP, SOCRA, or equivalent preferred.
• Experience with Good Clinical Practice (GCP), ISO14155 and/or regulatory compliance guidelines for clinical trials/data collection.
• Ability to appropriately apply different standards related to medical devices/ clinical research (SOPs, GCP, ISO, ICH, FDA, MedDev, etc.), as needed.
• Highly desired: experience with audits/compliance within clinical/quality/regulatory and regulatory inspections (e.g., FDA – BIMO, Notified Body (Europe)), and ability to support trial master file remediation and BIMO audit prep, working independently with minimal guidance.
• Ability to incorporate and adhere to applied standard practices and regulatory standards.
• Clinical Research experience at Medtronic or within the medical device industry or pharmaceutical industry.
• Experience in sponsor-initiated clinical trial experience managing clinical site personnel.
• Experience working with the clinical study lifecycle (e.g., planning, execution, and closeout).