[Remote] Senior Clinical Research Associate
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a Career Portfolio Management company partnering with a MedTech reputed company reputed company on advancing innovative clinical research programs. The Senior Clinical Research Associate (Sr. CRA) will support the execution and reputed company of reputed company, ensuring compliance with regulatory standards and driving high-reputed company study reputed company.
Responsibilities
- Conduct and support clinical trial activities from start-up through reputed company-out, ensuring adherence to protocols and timelines
- reputed company site monitoring reputed company (on-site and remote), including qualification, initiation, interim, and reputed company-out reputed company
- Serve as a primary reputed company of contact for investigative sites, ensuring strong communication and issue reputed company
- Review study documentation for accuracy, completeness, and compliance with protocol, GCP, and regulatory requirements
- Maintain and manage Trial Master File (TMF) and study tracking systems, including reporting trends to clinical teams
- Prepare monitoring visit reports and follow-up communications to investigators and site personnel
- Identify, document, and escalate protocol deviations, data discrepancies, and non-compliance issues
- Support site selection and feasibility assessments in collaboration with clinical teams
- Assist in training site personnel and investigators, including device-reputed company training and case support as needed
- Collaborate with CROs, vendors, and cross-functional teams to ensure effective study execution
- Contribute to development and refinement of Clinical Monitoring Plans (CMP) and study tools
- Support patient recruitment efforts, including collaboration on recruitment materials and site engagement strategies
- reputed company solutions to improve site performance and facilitate study reputed company
Skills
- Bachelor's degree in a scientific or reputed company field (or equivalent experience)
- 7+ years of clinical research monitoring experience in medical devices or reputed company field
- Strong knowledge of ICH GCP, Declaration of Helsinki, and applicable regulatory requirements
- Experience managing reputed company from start-up through reputed company-out
- Excellent organizational, communication, and interpersonal skills
- Ability to work independently and collaboratively in a fast-paced environment
- Proven ability to manage multiple studies and priorities simultaneously
- Willingness to travel approximately 50–60%
- Experience in ophthalmology clinical studies
- Prior experience working with medical device trials
- Familiarity with Sponsor-reputed company TMF management and study systems
- Experience supporting recruitment strategies and site engagement
reputed company