Den Jobinserenten von Allucent direkt kontaktieren
Ariane des Tombe
Global Head, Talent Acquisition at Allucent
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 looking for a Clinical Research Associate II (CRAII) to join our A-team (hybrid*/remote). As a CRAII at Allucent, you will independently control and monitor investigation sites, pro-actively detect issues, provide 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.
In this role your key tasks will include{{:}}
Governs quality standards for trial monitoring activities
Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule. Adheres to project guidelines and Allucent SOPs for monitoring requirements
Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols
Tracks and supervises collection of ongoing study data for purpose of regular project status reporting
Collects and reviews regulatory documents as required
Prepares site visit reports and telephone contact reports
Maintains and updates CTMS in compliance with SOPs and study-specific directives
Acts as Document Owner for collected documents
May participate in the start-up process including preparing Informed Consent forms, developing study documents, EC / CA submissions, and / or site contract management
Aims to pro-actively prevent and / or mitigate issues. Resolves site issues, including site recruitment challenges, and determines status for IP shipment
Acts as the main line of communication between the project team and the site staff
Works in collaboration with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities to facilitate oversight of the study conduct at the sites and prevent issues. Activities are related to but not limited to{{:}} Investigational Product supplies, non-IP study supplies, subject eligibility, protocol compliance, facilities, and PI oversight
Identifies potential logistical/practical problems and support Project team to create solutions / contingency plans, with timeframes for resolution
Ensures the continuous maintenance of the Trial Master File and Investigator Site File
Assists the Project Manager (PM) and Clinical Team Leader (CTL) with generation of study specific forms for completion by CRA and Investigators and follow up with the teams to ensure timely completion and submission
Works with Project Manager (PM); Clinical Team Leader (CTL), SSU (Study Start Up) team members or sponsor to ensure authorization of regulatory documents and site contracts
Attends Investigator Meetings (IM) to include organizing and presenting at investigator meetings. and study specific training meetings
May translate, coordinate translations or review completed translations of the essential documents as required
May participates in feasibility and/or site identification activities. Contacts local opinion leaders, medical consultants or specified investigators and identifies sites with the potential for participation. May follow feasibility procedures for documentation of feasibilities performed in collaboration with the Study Start Up Department
Where applicable, identifies the documentation required for review by Regulatory Authorities and Ethical Committees. May prepare Regulatory and Ethics Committee submissions working in conjunction with Study Start Up Department. Ensure written approvals are obtained and distributed appropriately prior to Site Initiation
Prepares and attends an Assessment Visit with a more senior CRA, CTL or Clinical Research Manager as required
May process 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
Assists the Project Team with the day-to-day management of critical studies as required, including attendance at team meetings
Provides secondary in-house review of CRFs (if required)
Support 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
May be assigned other tasks / activities / responsibilities related to the study execution in the country
May support initiatives in the country, GCO, and / or CTO to contribute to improvements and quality
Must work both independently and in a team environment
Requirements
To be successful you will possess{{:}}
At least three years clinical monitoring experience and/or relevant clinical trial experience
Relevant life science degree / health care / nursing background and/or related degree
Sound knowledge of medical terminology and clinical monitoring process
Strong communication in Local and English language in both written and verbal skills
Strong interpersonal and organizational skills
Ability to translate guidelines, rules and regulations in clear and usable recommendations
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
In-depth therapeutic and protocol knowledge
Ability to travel for up to 8 days on site per month, depending on the project needs
In-depth therapeutic and protocol knowledge as provided in previous, or company provided training
Attention to detail
Ability to work independently and to effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients
Demonstrated ability to manage multiple projects
Administrative excellence
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues
Ability to manage multiple projects
To be successful you will possess{{:}}
At least three years clinical monitoring experience and/or relevant clinical trial experience
Relevant life science degree / health care / nursing background and/or related degree
Sound knowledge of medical terminology and clinical monitoring process
Strong communication in Local and English language in both written and verbal skills
Strong interpersonal and organizational skills
Ability to translate guidelines, rules and regulations in clear and usable recommendations
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
In-depth therapeutic and protocol knowledge
Ability to travel for up to 8 days on site per month, depending on the project needs
In-depth therapeutic and protocol knowledge as provided in previous, or company provided training
Attention to detail
Ability to work independently and to effectively prioritize tasks, establish, and maintain strong working relationships with co-workers, managers, investigators, site personnel and clients
Demonstrated ability to manage multiple projects
Administrative excellence
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Demonstrated ability to develop, organize and manage new skills and tasks and mentor colleagues
Ability to manage multiple projects
Benefits
Benefits of working at Allucent include{{:}}
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
Disclaimers{{:}}
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within 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."
Karrierestufe
Berufserfahren
Beschäftigungsverhältnis
Vollzeit
Tätigkeitsbereich
Forschung, Analyst und IT
Branchen
Technologie, Information und Internet
Mit einer Empfehlung lassen sich Ihre Chancen auf ein Vorstellungsgespräch bei Allucent verdoppeln.