Job Description

HM's top 3:

1. Experience working on clinical research studies
2. Good understanding of ISO 14155 2020 standards
3. Experience managing sites that participate in a clinical research study

Education Required: Bachelor’s degree or higher education

Years’ Experience Required: 4 years

40 hours per week

Remote
Responsibilities may include the following:

• Manage clinical study sites by frequent communication with sites to ensure they have the proper documetation and training to begin enrolling subjects, as well as ensure sites are maintaining compliance by enrolling, submitting data, resolving queries, and resolving action items.
• Ensure sites are conducting activites per thier protocol, local IRB requirements, and executed contract.
• Frequent communication with the study lead on site status uppdates as well as internal leadership.
• Responsibilities may also include supporting study document creation and/or updates.
• Must follow company policies, good clinical practices (GCPs), good documentation practices (GDP), and local laws and regulations.
• Other duties may be assigned

Job may require up to 20% travel for site initation visits, physician enagement sessions, and other site support.

• Clinical Research experience in medical device industry
• Clinical Research experience at this company 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)
• 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.

Job Tags

Remote job, Contract work, Local area,

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