Remote Senior Clinical Research Associate

Summary

Join Allucent as a Sr. Clinical Research Associate (Sr. CRA) and contribute to the efficient navigation of clinical trials for small-medium biopharmaceutical companies.

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. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions
• 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

• 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