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, 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.
Opis
- 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.
Zahteve
- 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.
Ugodnosti
- Remote work arrangement.
- Regular employment contract.
- Opportunity to collaborate with a global team.
- Referral application opportunity.