Clinical Research Associate Lead
Vor 5 Tagen
At Allucent, we are committed to empowering biopharmaceutical companies to navigate the complex landscape of clinical trials and bring life-changing therapies to patients worldwide. As a growing organization, we are seeking an experienced Clinical Research Associate Lead to join our dynamic team.
We offer a competitive salary range of $90,000 - $120,000 per annum, depending on experience, as well as a comprehensive benefits package, flexible working hours, and opportunities for remote work. Our company culture prioritizes collaboration, innovation, and continuous learning, making us an ideal place for professionals looking to grow their careers.
About the RoleThe Clinical Research Associate Lead will be responsible for overseeing clinical trial monitoring activities, ensuring adherence to regulatory guidelines, and fostering strong relationships with site staff and project teams. Key responsibilities include:
- Governance of quality standards for trial monitoring activities;
- Selection, initiation, monitoring, and closure visits at investigator sites, adhering to project schedules and guidelines;
- Monitoring activities at clinical study sites to ensure adherence to GCP, ICH, SOPs, and study protocols;
- Tracking and supervising collection of ongoing study data for regular project status reporting;
- Collection and review of regulatory documents as required;
- Preparation of site visit reports and telephone contact reports;
- Maintenance and updates of CTMS in compliance with SOPs and study-specific directives;
- Acting as Document Owner for collected documents;
- Participation in the start-up process, including preparing informed consent forms, developing study documents, EC/CA submissions, and/or site contract management;
- Aims to proactively prevent and/or mitigate issues, resolves site issues, determines IP shipment status, and acts as the main line of communication between the project team and site staff;
- Collaboration with the Centralized Monitoring Team to evaluate risk-based monitoring activities, facilitating oversight of study conduct at sites and preventing issues;
- Identification of potential logistical/practical problems, supporting the project team in creating solutions/contingency plans with timeframes for resolution;
- Ensuring continuous maintenance of the Trial Master File and Investigator Site File;
- Assistance to the Project Manager and Clinical Team Leader in generating study-specific forms for completion by CRA and Investigators, following up with teams to ensure timely completion and submission;
- Work with the Project Manager, Clinical Team Leader, SSU team members, or sponsors to ensure authorization of regulatory documents and site contracts;
- Attendance at Investigator Meetings, organizing and presenting at IMs and study-specific training meetings;
- Translation, coordination of translations, or review of completed translations of essential documents as required;
- Participation in feasibility and/or site identification activities, contacting local opinion leaders, medical consultants, or specified investigators, identifying sites with potential participation;
- Identification of documentation required for review by Regulatory Authorities and Ethical Committees, preparation of Regulatory and Ethics Committee submissions in conjunction with the Study Start-Up Department;
- Preparation and attendance at Assessment Visits with a more senior CRA, CTL, or Clinical Research Manager as required;
- Processing of interim and final payments to Investigators, including preliminary calculations, review and approval from Project Management, liaison with finance, logging trial expenditure, receipts, invoices, and income;
- Support to the Project Team with day-to-day management of critical studies as required, including attendance at team meetings;
- Secondary in-house review of CRFs (if required);
- Support to site staff in preparation for study-related site audits and inspections;
- Reporting of Quality Issues and support to root cause analysis, writing of and resolution of Corrective and Preventative Actions when applicable.
To be successful, you will possess:
- At least 5 years of clinical monitoring experience;
- Relevant life science degree/healthcare/nursing background and/or related degree;
- Sound knowledge of medical terminology and clinical monitoring processes;
- Ability to travel for up to 8 days on-site per month, depending on project needs;
- Strong communication skills in English, both written and verbal;
- Strong interpersonal and organizational skills;
- Ability to translate guidelines, rules, and regulations into clear and usable recommendations;
- Representative, outgoing, and client-focused personality traits;
- Attention to detail;
- Ability to manage multiple projects;
- Ability to work in a fast-paced, challenging environment of a growing company;
- In-depth therapeutic and protocol knowledge;
- Ability to work independently and effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel, and clients;
- Demonstrated ability to manage multiple projects;
- Proficiency with various computer applications such as Word, Excel, and PowerPoint required.
We offer a comprehensive benefits package, including:
- Competitive salaries ranging from $90,000 to $120,000 per annum, depending on experience;
- Flexible working hours within reason;
- Opportunities for remote/hybrid work depending on location;
- Departmental Study/Training Budget for furthering professional development;
- 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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