Allucent is hiring a
Sr. Clinical Research Associate, Remote - France
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Summary
The job is for a Senior Clinical Research Associate at Allucent™. The role involves managing clinical studies, providing functional assistance, tracking study data, conducting feasibility assessments, and ensuring compliance with regulations. The candidate should have 4+ years of experience, strong therapeutic background, excellent communication skills, and ability to travel up to 8 days per month.
Requirements
- At least 4 years experience
- Skills to mentor and train other CRAs in a positive and effective manner
- In-depth knowledge of clinical trials and the critical elements for success in clinical trials
- Ability to travel for up to 8 days on site per month, depending on the project needs
- Strong therapeutic background
- Has shown ability to successfully manage people/project issues
- Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems
- Demonstrates the ability to define and meet project requirements
- Can demonstrate flexibility for improvement and creating solutions
- Proven organizational abilities, and excellent written and oral communication and presentation skills
- Excellent team player with team building skills
- Strong customer focus
- A thorough knowledge of regulatory submission and reporting requirements and guidelines
- Excellent understanding of the drug development process
Responsibilities
- Independently control and monitor investigational 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
- Provide functional assistance to the project team members with administrative, logistical and practical issues
- Track and supervise collection of ongoing study data for purpose of regular project status reporting as required
- Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies
- Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members
- Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols
- Collect and review regulatory documents as required
- Prepare site visit and telephone reports
- Responsible for multiple projects and must work both independently and in a team environment
- May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training
- Resolve site issues and determine status for IP shipment
- Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts
- May translate, coordinate translations or review completed translations of critical documents
- Participate in feasibility and/or site identification activities
- Assist the Project Team with the day-to-day management of clinical studies as required
- Monitoring Visit Report (MVR) review, management, resolution and escalation as required
- Train, mentor and/or supervise junior staff
- May be assigned as LCRA to a regional or global study
- May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR)
- Conducts project co-monitoring, assessment visits and team training
- Site contact for protocol clarifications and subject enrolment if CRA unavailable
- Participate in the development of study newsletters communication as required
- Assist with the development of project-specific training materials for team
- Liaise with Business Development and make presentations to potential clients as required
- May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices)
Benefits
- 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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