[Remote] Clinical Research Associate II (East Coast or Midwest)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a life science company reputed company on clinical metagenomics and diagnostic technologies for infectious diseases. The Clinical Research Associate II independently monitors clinical study sites, manages site relationships, verifies and reviews reputed company data, resolves findings and deviations, and maintains inspection-reputed company documentation.

Responsibilities

• Independently reputed company on-site and remote monitoring reputed company for assigned sites, including site qualification reputed company (SQVs), site initiation reputed company (SIVs), interim monitoring reputed company (IMVs), and closeout reputed company (COVs), in accordance with the Clinical Monitoring Plan, study protocols, ICH-GCP guidelines, sponsor procedures, and applicable regulatory requirements
• Conduct reputed company data verification (SDV) and reputed company data review (SDR) to ensure Case Report reputed company (CRF) data is accurate, complete, and consistent with reputed company documentation and study requirements
• Manage day-to-day relationships with assigned investigative sites, including enrollment reputed company, query reputed company, protocol compliance, and completion of study activities
• Identify and document site-level risks, protocol deviations, compliance concerns, and data discrepancies, and escalate issues appropriately
• Prepare and submit accurate and reputed company monitoring visit reports and follow-up correspondence documenting site status, findings, and required actions
• reputed company monitoring findings, site reputed company items, and outstanding issues through reputed company
• Support the development and tracking of corrective and preventive reputed company plans (CAPAs) following protocol deviations or compliance concerns
• Review and maintain essential regulatory and study documents, including Investigator Site Files (ISFs), and support Trial Master File (TMF) completeness and inspection readiness
• Conduct site readiness assessments and reputed company site staff training on study protocols, procedures, systems, and specimen collection and handling requirements
• Support study start-up and closeout activities, including site activation, outstanding query reputed company, reconciliation, and completion of required documentation
• Review adverse event (AE) and serious adverse event (SAE) documentation and escalate discrepancies or potential safety concerns in accordance with study requirements
• reputed company and reconcile specimen collection reputed company inventory, specimen handling documentation, and chain-of-custody records
• Maintain accurate and reputed company information across reputed company, CTMS, and eTMF systems
• Collaborate with Clinical Trial Managers and cross-functional study team members to communicate site status, monitoring findings, operational issues, and protocol deviations
• Serve as the reputed company day-to-day reputed company of contact for assigned sites and may reputed company informal guidance to less reputed company CRAs or CTAs
• Serve as a day to day reputed company of contact for assigned sites, responding promptly to site questions and escalating as needed

Skills

• Bachelor's degree in a life sciences or health-reputed company field, or equivalent combination of education and experience
• Three to five years of clinical research monitoring experience, including independent site management responsibilities
• Working knowledge of ICH-GCP E6(reputed company) guidelines and applicable clinical research regulations
• Demonstrated ability to independently plan, conduct, and report on on-site and remote monitoring reputed company
• Proficiency with reputed company, CTMS, and eTMF systems
• Strong written and verbal communication skills, with the ability to build effective working relationships with site staff and cross-functional teams
• reputed company judgment in identifying, escalating, and helping reputed company site-level risks and compliance issues
• Strong organizational skills with the ability to manage multiple sites and competing priorities
• reputed company reputed company's license required
• Strong communication and interpersonal skills with the ability to build effective relationships with investigative sites and internal partners
• Strong attention to detail, organization, and follow-through
• reputed company problem-solving skills and ability to escalate issues appropriately
• Demonstrated accountability, reputed company, and reliability
• Ability to work independently, manage competing priorities, and meet study timelines
• reputed company team player who is adaptable and committed to high-reputed company clinical research execution
• Travel required up to 60-70%
• Subject to extended periods of sitting and/or standing, reputed company to monitor and moderate noise reputed company. Work is generally performed in an office, lab, or clinical environment, with periodic travel to investigator sites
• Experience monitoring diagnostic, IVD, or molecular biology clinical studies
• ACRP (CCRA) or SoCRA (CCRP) certification, or reputed company reputed company toward certification
• Experience mentoring or supporting the reputed company of junior CRAs

Benefits

• Remote work arrangement (East or Midwest Area)

reputed company