Clinical Research Associate II
3 weken geleden
At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
We are seeking a highly skilled Clinical Research Associate II to join our team. As a CRA II, you will play a critical role in ensuring the success of our clinical trials by monitoring investigational sites, detecting issues, and providing solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs, applicable regulations, and the principles of Good Clinical Practice.
Key Responsibilities:- Govern highest possible quality standards for trial monitoring activities.
- Conduct all study tasks in compliance with quality, while preserving efficiency and in alignment to the scope of services and budgeted hours.
- Monitor activities at clinical study sites to assure adherence to protocol, Monitoring Plan, ICH, GCP, SOPs, and applicable regulations and guidelines.
- Perform efficient site management in line with study budget.
- Prepare and submit quality Site Visits Reports and Contact reports.
- Maintain and update CTMS in compliance with SOPs and study-specific directives.
- Act as Document Owner for collected documents.
- Conduct co-monitoring as needed.
- Provide functional assistance to the project team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation (CTMS, TMF).
- Liaise with project team members and Sponsor to track study progress and milestones.
- Track and supervise collection of ongoing study data for purpose of regular project status reporting within agreed timelines.
- May review essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
- May participate in organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project specific CRA training.
- May perform assessment visits.
- Represent Allucent in the global medical research community, develop and maintain collaborative relationships with investigational sites and sponsor company personnel.
- Identify potential logistical/practical problems and propose solutions / contingency plans, with timeframes for resolution.
- Supervise generation of electronic tracking systems and logs to produce status updates, progress reports and general management of the clinical deliverables when needed.
- May process and track payments to the Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators and /or vendors including timely notification to finance department, as applicable.
- May participate in meetings with clients.
- May support project manager/CTL and project functional leads in the project oversight and management.
- Supports site staff in preparation for study related site audits and inspections.
- Where applicable, reports Quality Issues and supports the root cause analysis, writing of and resolution of the Corrective and Preventative Actions.
- At least two years clinical monitoring experience and/or relevant clinical trial experience.
- Relevant life science degree / medical / nursing background, or combination of education and experience.
- Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures.
- Ability to travel for up to 8 days on site per month, depending on the project needs.
- Strong written and verbal communication skills including good command of English and local language.
- Representative, outgoing and client focused.
- Ability to work in a fast-paced challenging environment of a growing company.
- Administrative excellence.
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
- Effective clinical monitoring skills (all kind of visits mastered).
- Demonstrated understanding of applicable medical/therapeutic area knowledge and medical terminology.
- In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
- Excellent understanding of the drug development process.
- Ability to proactively identify and resolve issues in a timely manner.
- Effective oral and written and presentation communication skills, with the ability to communicate effectively with medical personnel.
- Effective organizational and time management skills.
- Ability to manage multiple projects and strong attention to detail.
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and clients.
- Ability to meet project requirements.
- Proven flexibility and adaptability.
- Ability to work in a team or independently and to effectively prioritize tasks.
- Comprehensive benefits package per location.
- Competitive salaries per location.
- Departmental Study/Training Budget for furthering professional development.
- Flexible Working hours (within reason).
- Opportunity for remote/hybrid working depending on location.
- Leadership and mentoring opportunities.
- Participation in our Buddy Program as a new or existing employee.
- Internal growth opportunities and career progression.
- Financially rewarding internal employee referral program.
- Access to online soft-skills and technical training via GoodHabitz and internal platforms.
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects.
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.
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