Sr. Clinical Research AssociateAlimentiv • Denver, Colorado, USA
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Sr. Clinical Research Associate
Alimentiv • Denver, Colorado, USA
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
Key Skills
CSS,Cloud Computing,Health Education,Actuary,Building Electrician
Employment Type : Full-Time
Experience: years
Vacancy: 1
Manage deliver and/or perform full clinical site monitoring services for one or more projects which may include multiple services be complex in nature and/or run on a multinational -house based position responsible for the design and oversight of project monitoring services including training site/patient recruitment site data/document management monitoring project site budgets and regulatory filings that aligns with SOPs study guidelines and GCP best the function of Lead CRA will act as primary liaison between CRAs and project team and may be required to participate in the development of project plans protocols CRFs communications or other monitoring forms documents and tools. Represents the corporation by maintaining collaborative relationships with stakeholders.
Positions available: 1 (remote based USA West coast)
Monitoring - Subject Expert
- Act as subject matter expert mentor coach and/or provide performance feedback to manager for peers.
- Assist with selection hiring training and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.
- When required act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.
- May represent Director Monitoring and Site Management or Manager Clinical Site Management in BD initiatives with a site monitoring focus.
Project Monitoring Lead
- May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.
- Function as liaison between CRAs and other functional teams escalating concerns and issues to management as needed.
- Participate and/or present at study team kickoff and investigator meetings and act as primary contact to sponsors for all monitoring related issues.
Site Recruitment and Setup
- Identify and recruit site investigators coordinate the movement and delivery of trial materials samples tests and forms including investigational product protocols SOPs CRFs project documents forms and support tools.
- Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.
Investigational Site Monitoring
- Primary clinical site contact.
- May act as primary contact for any questions or issues that arise from investigational sites.
- Oversee overall integrity of the study to promote positive working relationships with the site and staff.
- Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.
- Ensure all site related issues are followed until resolution.
- Coordinate delivery of clinical sites communications collaborating with project teams to ensure investigational sites are provided accurate ongoing data updates information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
Qualifications
- The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.
- Self-motivation with strong communication skills and a commitment to achieving positive results.
- Strong attention to detail and keenness to understand the importance of building collaborative relationships to achieve results.
- Critical thinking abilities
- Ability to regularly travel to sites.
Working Conditions
- Home-based
- Regular travel is required
$86000 - $143000 a year
bonus
PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams leveraging various methods of attack via email text voice and social media. Please note that Alimentiv only uses company email addresses which contain @ to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv please verify the domain of the senders email address and that they are asking you to apply on this website. If you believe youve been a victim of a phishing scam please contact your local government cyber authority to report.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
Senior IC
Key Skills
CSS,Cloud Computing,Health Education,Actuary,Building Electrician
Employment Type : Full-Time
Experience: years
Vacancy: 1
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