What are the responsibilities and job description for the Remote Sr Clinical Research Spec position at Planet Pharma?
Descriptions
Job Description
Responsibilities May Include The Following
Years’ Experience Required: 4 years
Technical Skills
Must Have
Job Description
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.
- Must follow company policies, good clinical practices (GCPs), good documentation practices (GDP), and local laws and regulations.
- Experience working on clinical research studies
- Experience with IDE studies and a good understanding of 21CFR812 FDA IDE regulations
- Experience managing sites that participate in a clinical research study
Years’ Experience Required: 4 years
Technical Skills
Must Have
- 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.
- 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 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)
- 3rd Party Audit Support
- accurate data analysis
