Develops and maintains liaison with clinical investigators, affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.
Responsible for reviewing adverse event and device deficiencies with investigators.
Review source documentation and case report forms for accuracy, completeness, and timely submission Conducts site qualification, initiation, monitoring and close-out visits Monitoring Action Item and query resolution Monitoring Visit Reports submission and completion
2+ 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.
Experience with audits/compliance within clinical/quality/regulatory and regulatory inspections (e.g., FDA – BIMO, Notified Body (Europe))
Ability to incorporate and adhere to applied standard practices and regulatory standards.
Experience in sponsor-initiated clinical trial experience managing clinical site personnel
Experience working with the clinical study lifecycle (e.g., planning, execution, and closeout)
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
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