501 – 1.000 Angajați
Sponsor pentru viza H1BAsigurare de sănătateAsistență medicalăIndustria prelucrătoareAlira Health este o companie globală de consultanță și tehnologie în domeniul sănătății, care oferă servicii organizațiilor din domeniul științelor vieții. Activitatea sa acoperă cercetarea și dezvoltarea clinică, conformitatea cu reglementările, consultanța managerială, implicarea pacienților și accesul pe piață, precum și soluții tehnologice concepute pentru a sprijini cercetarea în științele vieții. Compania pune accent pe empatie, excelență științifică, rezultate mai bune pentru pacienți, sustenabilitate ecologică, implicare comunitară și inițiative ESG.
Clinical Research Associate, Wound Care
Monitor wound-care clinical trials for Alira Health, conducting remote and on-site visits. Ensure GCP compliance, reliable study data, and quality at research sites.
Descriere
- Monitor clinical trial sites and study activities.
- Oversee trial management and execution, providing guidance to study teams.
- Maintain protocol compliance and clinical trial quality.
- Review monitoring reports and conduct co-monitoring and evaluation visits.
- Keep investigator site visits on schedule.
- Coordinate with cross-functional teams to address monitoring issues.
- Contribute to study monitoring plans and training materials.
- Collect site ethics documents and support contract negotiations.
- Submit monthly billing information to Finance.
- Manage study budgets and serve as sponsor contact for standalone projects.
- Conduct remote and on-site qualification, initiation, interim, and close-out visits.
- Document site issues, resolutions, protocol deviations, study progress, and enrollment in monitoring reports.
- Review source records and verify the integrity of case report form data.
- Perform quality checks and verify documents in electronic and paper trial master files.
- Track investigational product accountability.
- Review site regulatory binders.
- Stay in contact with sites about protocol and GCP compliance, patient enrollment, and sponsor requests.
- Follow ICH GCP, FDA regulations, and company and sponsor procedures.
- Attend internal, sponsor, scientific, and other meetings.
- Support adverse event reporting and reconcile serious adverse event reports against source records and case report forms.
- Resolve data discrepancies with in-house CRAs, clinical trial coordinators, and data management.
- Identify site challenges and develop solutions.
- Prepare study sites for audits.
- Work collaboratively with other CRAs.
- Support CRA onboarding and new-hire training.
- Mentor CRAs.
- Contribute to the development and maintenance of the clinical trial management system.
- Balance competing priorities and meet commitments.
- Complete other assigned duties.
Cerințe
- At least two years of wound-care monitoring experience.
- Ability to build and maintain positive relationships with sponsors, sites, and project team members.
- Ability to manage monitoring activities independently.
- Quality focused, thorough, and attentive to detail.
- Strong organization and multitasking skills in a fast-paced environment.
- Ability to prioritize, manage time, and solve problems.
- Strong analytical, negotiation, meeting management, cross-functional collaboration, and leadership skills.
- Willingness and ability to travel.
- Ability to manage stress.
- Professional, trustworthy, and disciplined approach.
- Ability to address unstructured or ambiguous challenges.
- Strong written and spoken command of the local language in the country where monitoring takes place.
- Excellent communication and interpersonal skills, with a customer service orientation.
- Good computer skills, including the ability to use clinical trial management systems, databases, and electronic data capture tools.
- Knowledge of clinical research, ICH GCP, and local regulations.
- Knowledge of regulatory and ethics requirements.
- English proficiency.
- Bachelor of Science degree in Biology or Life Sciences.
Beneficii
- Remote work arrangement.
- Regular employment contract.
- Opportunity to collaborate with a global team.
- Referral application opportunity.