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Clinical Research Associate
Beacon Hill Pharma is currently hiring a Clinical Research Associate for a remote opportunity!
- Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness for activation.
- Participates in and provides input on site selection and validation activities.
- Performs remote and on-site monitoring and oversight activities using various tools to ensure:
- Data generated at the site are complete, accurate and unbiased.
- Subjects' rights, safety and well-being are protected.
- Conducts on-site visits including but not limited to qualification, initiation, interim monitoring, and close-out visits.
- Records clear, comprehensive, and accurate visit summary reports and submits them within TH specified timeframe.
- Collaborates with the Clinical Trial Associate (CTA) to collect, review, and QC required regulatory documentation for study start-up, maintenance, and close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
- Identifies, assesses, and resolves site performance, quality, or compliance problems, and escalates as appropriate to the Clinical Trial Manager (CTM), Lead CRA, and Project Manager.
- Conducts various monitoring activities through available tools including EDC, eTMF and CTMS and/or other management systems.
- Contributes to the development of CRA knowledge base, subject matter expertise (SME), and sharing of best practices.
- Supports and/or leads audit/inspection activities as needed.
- Mentor/train other Clinical Research Associate team members.
REQUIRED EXPERIENCES TO APPLY FOR POSITION:
- B.A./B.S. degree required; strong emphasis in science and/or biology preferred.
- Minimum of 2 years (CRA II) and 4 years (Sr. CRA) of direct site management (monitoring) experience in Bio/Pharmaceuticals/Clinical Research Organization
- Fluent in English (verbal and written) with excellent communication skills, including the ability to understand and present technical information effectively.
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonization Good Clinical Practice (GCP/ICH) and country-specific clinical research law and guidelines.
- Excellent understanding of Global, Country/Regional Clinical Research Guidelines, and ability to work within these guidelines.
- Demonstrates the ability to mentor/lead.
- Hands-on knowledge of Good Documentation Practices.
- Proven skills in Site Management including independent management of site performance and patient recruitment.
- Demonstrates high level of monitoring skill with independent professional judgment.
- Proficiency in the use of MS Office, Excel, various EDC and monitoring applications, and the ability to adapt to new IT technology on various electronic devices.
- Ability to understand and analyze data/metrics and apply them for continuous quality improvement.
- Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP) preferred.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.
We look forward to working with you!
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