„Alira Health“ yra pasaulinė sveikatos priežiūros konsultavimo ir technologijų įmonė, teikianti paslaugas gyvybės mokslų organizacijoms. Jos veikla apima mokslinius tyrimus ir klinikinę plėtrą, reguliavimo reikalavimų laikymąsi, vadybos konsultavimą, pacientų įtraukimą ir patekimą į rinką, taip pat technologinius sprendimus, skirtus gyvybės mokslų tyrimams remti. Įmonė pabrėžia empatijos, mokslinės kompetencijos, pacientų gydymo rezultatų, aplinkos tvarumo, dalyvavimo bendruomenės veikloje ir ESG iniciatyvų svarbą.
Clinical Research Associate, Wound Care (Massachusetts Remote)
Alira Health seeks a Clinical Research Associate to monitor wound care trials. The role includes remote and onsite visits, GCP compliance, and oversight of study data and quality.
Aprašymas
- Monitor clinical trial sites.
- Oversee trial management and execution to support compliance and quality.
- Guide the CRA team on project scope, SOPs, timelines, and budgets.
- Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed.
- Ensure investigator site visits are appropriate and timely.
- Coordinate across departments to resolve trial monitoring issues.
- Help prepare study monitoring plans and training presentations.
- Assist with site ethics documents and contract negotiations.
- Send monthly billing information to Finance.
- Manage study budgets and serve as sponsor contact for standalone projects.
- Conduct qualification, initiation, interim, and close-out visits remotely and onsite.
- Prepare monitoring reports documenting site issues and resolutions, protocol deviations, study progress, and enrollment.
- Verify source documents and maintain CRF data integrity.
- Conduct quality control and verification of eTMF/TMF documents.
- Track investigational product accountability.
- Review site regulatory binders.
- Stay in contact with sites about protocol and GCP compliance, patient accrual, and sponsor requests.
- 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 queries with in-house CRAs, CTC, and data management.
- Identify site issues and develop solutions.
- Prepare study sites for audits.
- Work with other CRAs.
- Support CRA new-hire training and onboarding.
- Mentor CRAs.
- Contribute to CTMS development and maintenance.
- Balance competing priorities and meet commitments.
- Carry out other assigned duties.
Reikalavimai
- 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, careful, thorough, and detail-oriented approach.
- Strong organization and ability to multitask effectively in a fast-paced environment.
- Ability to prioritize, organize time, and solve problems.
- Strong analytical, negotiation, meeting management, cross-functional teamwork, and leadership skills.
- Willingness and ability to travel.
- Ability to manage stress.
- Professional, trustworthy, and disciplined conduct.
- Ability to solve unstructured or ambiguous problems.
- Strong written and spoken command of the local language where monitoring takes place.
- Excellent communication and interpersonal skills with a customer service orientation.
- Good computer skills, including experience with clinical trial management systems, trial databases, and electronic data capture.
- Self-directed approach and ability to thrive in a collaborative, less structured team.
- Knowledge of clinical research, ICH GCP, and local regulations.
- Knowledge of regulatory and ethical requirements.
- English language proficiency.
- Bachelor of Science in Biology or Life Sciences.