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About Allucent
At Allucent, we are committed to assisting small to medium-sized biopharmaceutical organizations in effectively navigating the intricate landscape of clinical trials, ultimately delivering transformative therapies to patients worldwide.
Position Overview
We are seeking a Clinical Research Associate II (CRA II) to become a vital part of our team (hybrid/remote). In this role, you will independently oversee and manage investigational sites, proactively identify challenges, and provide solutions to ensure that clinical studies are conducted in accordance with the trial protocol, as well as in compliance with Standard Operating Procedures (SOPs), relevant regulations, and the principles of Good Clinical Practice (GCP).
Key Responsibilities
- Ensure the highest quality standards for trial monitoring activities.
- Conduct all study-related tasks in compliance with quality standards while maintaining efficiency and adhering to the scope of services and budgeted hours.
- Monitor activities at clinical study sites to ensure adherence to the protocol, Monitoring Plan, ICH guidelines, GCP, SOPs, and applicable regulations.
- Manage site operations in alignment with study budgets.
- Prepare and submit comprehensive Site Visit Reports and Contact Reports.
- Maintain and update the Clinical Trial Management System (CTMS) in accordance with SOPs and study-specific directives.
- Act as Document Owner for all collected documentation.
- Conduct co-monitoring as required.
- Provide functional support to project team members with administrative, logistical, and practical matters, including tracking, collecting, distributing, and filing study documentation (CTMS, TMF).
- Collaborate with project team members and sponsors to monitor study progress and milestones.
- Track and supervise the collection of ongoing study data for regular project status reporting within agreed timelines.
- May review essential documents (GLP) as a second line or Independent Reviewer (IR).
- May assist in organizing and presenting at investigator meetings, collaborating with management on monitoring strategies, and/or developing project-specific CRA training.
- May conduct assessment visits.
- Represent Allucent within the global medical research community, fostering and maintaining collaborative relationships with investigational sites and sponsor personnel.
- Identify potential logistical or practical challenges and propose solutions or contingency plans with timelines for resolution.
- Oversee the generation of electronic tracking systems and logs to produce status updates, progress reports, and manage clinical deliverables as needed.
- May process and track payments to Institutional Review Boards (IRB), Ethics Committees (EC), Regulatory Authorities, Investigators, and/or vendors, including timely notifications to the finance department as applicable.
- May participate in client meetings.
- May support project managers/CTL and project functional leads in project oversight and management.
- Assist site staff in preparing for study-related audits and inspections.
- Where applicable, report Quality Issues and support root cause analysis, writing, and resolution of Corrective and Preventative Actions.
Qualifications
- A minimum of two years of clinical monitoring experience and/or relevant clinical trial experience.
- A relevant life science degree, medical, or nursing background, or a combination of education and experience.
- Strong understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures.
- Willingness to travel for up to 8 days on-site per month, depending on project needs.
- Excellent written and verbal communication skills, including proficiency in English and the local language.
- Professional, outgoing, and client-focused demeanor.
- Able to thrive in a fast-paced, challenging environment of a growing organization.
- Demonstrated administrative excellence.
- Proficiency in various computer applications such as Word, Excel, and PowerPoint.
- Effective clinical monitoring skills across all types of visits.
- Comprehensive understanding of applicable medical/therapeutic area knowledge and medical terminology.
- In-depth knowledge of clinical trials and the critical elements necessary for success.
- Strong grasp of the drug development process.
- Ability to proactively identify and resolve issues promptly.
- Effective oral, written, and presentation communication skills, with the ability to engage with medical personnel.
- Strong organizational and time management skills.
- Ability to manage multiple projects with a keen attention to detail.
- Capacity to establish and maintain effective working relationships with colleagues, managers, investigator site personnel, and clients.
- Ability to meet project requirements consistently.
- Proven flexibility and adaptability.
- Ability to work both independently and as part of a team, effectively prioritizing tasks.
Benefits
Working at Allucent offers:
- A comprehensive benefits package tailored to location.
- Competitive salaries based on location.
- A departmental study/training budget for professional development.
- Flexible working hours (within reason).
- Opportunities for remote/hybrid working based on location.
- Leadership and mentoring opportunities.
- Participation in our Buddy Program for new or existing employees.
- Internal growth opportunities and career advancement.
- A financially rewarding internal employee referral program.
- Access to online soft-skills and technical training through GoodHabitz and internal platforms.
- Eligibility for our Spot Bonus Award Program in recognition of exceptional project contributions.
- Eligibility for our Loyalty Award Program to acknowledge long-standing employee commitment.
Disclaimer:
*Our hybrid work policy promotes a dynamic work environment, encouraging two days in the office per week for employees within a reasonable distance from one of our global offices.
The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.
