Clinical Research Manager
4 days ago
We are seeking a highly skilled and experienced Clinical Research Manager to join our team at Eximia Research. As a key member of our clinical research team, you will be responsible for the clinical safety of patients participating in clinical trials, collecting and recording accurate clinical data, and ensuring the well-being and interests of subjects enrolled in studies are met.
Key Responsibilities- Study Execution
- Lead a study team to execute clinical trials in accordance with study protocols, GCP, ICH Guidelines, and Eximia's SOPs.
- Develop and implement training strategies and mitigation plans for staff.
- Team Management
- Mentor and train staff in clinical trials, protocol requirements, communication, and trial management skills.
- Develop and coordinate research and administrative strategies to successfully manage assigned protocols.
- Communication and Documentation
- Ensure good documentation practices are applied by team members when collecting and correcting data.
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
- Regulatory Compliance
- Ensure confidentiality of patient protected health information, sponsor confidential information, and Eximia confidential information.
- Develop and implement strategies to ensure regulatory compliance with HIPAA requirements.
- Quality Control
- Develop Quality Control strategies for team member projects.
- Perform clinical duties within scope, including drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing.
- Education and Experience
- Must be a licensed MD, DO, NP, or PA.
- 5+ years of clinical management experience or equivalent applicable experience in clinical research industry.
- Skills and Abilities
- Must be licensed as a MD, DO, NP, or PA in the state you work in.
- Must undertake all training and certification required by sponsors and CRO's to carry out clinical trials within specified timelines.
- Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements.
- Ability to communicate effectively in English (both verbal and written).
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
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