Alira Health je globalno svetovalno in tehnološko podjetje na področju zdravstva, ki nudi storitve organizacijam v panogi znanosti o življenju. Njegovo delo zajema raziskave in klinični razvoj, skladnost z regulativnimi zahtevami, poslovno svetovanje, vključevanje pacientov in dostop do trga ter tehnološke rešitve, namenjene podpori raziskavam v panogi znanosti o življenju. Podjetje poudarja empatijo, znanstveno odličnost, izide zdravljenja pacientov, okoljsko trajnost, vključenost v skupnost in pobude ESG.
Clinical Research Associate – Massachusetts Remote
Monitor clinical trials for Alira Health, supporting protocol compliance, site quality, regulatory requirements, and reliable clinical data.
Opis
- Monitor clinical trial sites and guide trial management and execution.
- Promote protocol compliance and trial quality.
- Review monitoring reports and carry out co-monitoring and evaluation visits.
- Keep investigator site visits on schedule.
- Coordinate across departments to resolve trial monitoring issues.
- Help develop study monitoring plans and training materials.
- Gather ethics documents and support site contract negotiations.
- Send monthly billing details to Finance.
- Oversee study budgets and serve as sponsor contact for standalone projects.
- Conduct remote and onsite qualification, initiation, interim, and close-out visits.
- Document site issues, resolutions, protocol deviations, study progress, and enrollment in monitoring reports.
- Review and verify source documents and CRF data.
- Check and verify eTMF/TMF documents for quality.
- Track investigational product accountability.
- Review site regulatory binders.
- Maintain site communication on protocol and GCP compliance and patient enrollment.
- Ensure compliance with ICH GCP, FDA regulations, and company and sponsor SOPs.
- Attend internal, client and sponsor, scientific, and other meetings.
- Support adverse event reporting and reconcile SAE reports against source documents and CRFs.
- Resolve data discrepancies with in-house CRAs, CTC, and data management.
- Identify site challenges and develop solutions.
- Prepare study sites for audits.
- Work collaboratively with other CRAs.
- Support CRA training and onboarding.
- Mentor CRAs.
- Contribute to CTMS development and maintenance.
- Balance competing priorities and meet commitments.
- Carry out other assigned duties.
- requirementsExtensions, none
Zahteve
- Build and maintain positive relationships with sponsors, sites, and project team members.
- Manage monitoring activities independently.
- Maintain a quality-focused, careful, thorough, and detail-oriented approach.
- Stay organized and manage multiple tasks in a fast-paced setting.
- Set priorities, manage time, and solve problems effectively.
- Bring strong analytical, negotiation, meeting management, cross-functional teamwork, and leadership skills.
- Be able to travel.
- Manage stress effectively.
- Demonstrate professionalism, trustworthiness, and discipline.
- Solve unclear or ambiguous challenges.
- Have strong written and spoken command of the local language in the country where monitoring is performed.
- Communicate and work with people effectively, with a customer service mindset.
- Use computers proficiently, including clinical trial management systems, trial databases, and electronic data capture tools.
- Know clinical research, ICH GCP, and local regulations.
- Understand regulatory and ethical requirements.
- Hold a Bachelor of Science degree in Biology or Life Sciences.
- Be proficient in English.
Ugodnosti
- Remote work arrangement.
- Regular employment contract.