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 (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.
Opis
- 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.
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, 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.