About The Role

The Lead Clinical Research Associate (Lead CRA/LCRA) is responsible for overseeing and coordinating clinical monitoring activities for assigned clinical trials, ensuring compliance with regulatory requirements, protocol adherence, and data integrity. The Lead CRA works closely with CRAs and the study team on assigned studies. The Lead CRA reports directly to a member of the Clinical Monitoring Management team, as defined in the current organizational chart.

What You'll Do Here

Under the guidance of Clinical Monitoring Management, the Lead CRA collaborates closely with the CRAs and the study team to plan, track, coordinate and drive clinical monitoring activities for assigned studies. Responsibilities include, but are not limited to:

• Supporting the planning, scheduling and tracking of visits
• Overseeing visit reporting as defined in the Clinical Monitoring Plan (CMP)
• Collaborating with the Data Management team to oversee SDV progress, query resolution, and timely data processing by the CRAs
• Developing the Clinical Monitoring Plan, including risk identification and mitigation strategies
• Preparing and providing training material (e.g., Site Initiation Visit / Investigator Meeting slides), as needed
• Reviewing monitoring visit reports for all visit types to ensure:
  
  • Compliance with protocol, plan and regulatory obligations
  • Appropriate performance of monitoring activities, including but not limited to protocol/process deviation reporting, ISF/TMF reconciliation and IP reconciliation
  • Escalation of issues
• Updating tracking systems
• Collecting clinical monitoring metrics
• Ensuring clinical monitoring study deliverables are communicated and met within timelines and budget and ensuring compliance with the approved protocol, plans, Good Clinical Practice (GCP), applicable regulations, and internal Standard Operating Procedures (SOPs)
• As needed, performing on-site and remote monitoring activities including, but not limited to, site qualification, initiation, interim and close-out visits according to the study-specific Clinical Monitoring Plan
• Other study activities, as requested by Clinical Monitoring Management

NON-STUDY ACTIVITY

Under the guidance of Clinical Monitoring Management, the Lead CRA will perform non-study activity in support of the overall Clinical Monitoring Team. Responsibilities include, but are not limited to:

• Preparing and delivering training and presentations
• Acting as a mentor for new Clinical Monitoring team members (e.g., CRA, LCRA), by providing guidance, support and training (initial and ongoing)
• Contributing to departmental SOP and process development and revision, and the implementation of systems
• Participation in audit preparation, conduct and follow-up activities, as needed
• Participation in CAPA implementation, as needed
• Reviewing study documents, as needed (e.g., protocol, ICF...)
• Other non-study activities, as requested by Clinical Monitoring Management

What You'll Need to Succeed

• Bachelor's degree in a scientific or healthcare-related field preferred
• Minimum of 5 years of experience in clinical research, with at least 2 years in a Senior CRA role (or equivalent) preferred
• Previous CRO experience is preferred
• Thorough knowledge and application of regulations governing clinical research (e.g., FDA, Health Canada) and ICH GCP
• Strong understanding of clinical trial conduct and site management
• Ability to perform risk assessment and management
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• Ability to plan, meet deadlines, multitask, and prioritize based on study needs
• Excellent communication (verbal and written), collaboration, and problem-solving skills
• Ability to make sound decisions based on available information
• Ability to establish and maintain a good working relationship with internal and external customers
• Ability to work both in a team and independently
• Ability to facilitate and present at team meetings
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems; ability to learn required systems quickly and to train others
• Certification in Clinical Research (e.g., CCRP, CCRA) is preferred

Altasciences strives to provide a French working environment for its employees in Quebec. Although as part of its francization program has taken all reasonable steps to avoid imposing the above-mentioned requirement. Fluency in English is an essential requirement for the position of Lead Clinical Research Associate including, but not limited to, for the following reasons:

• The requirement to have study protocols, designs and clinical research documents written and documented in English as required by industry regulatory agencies.
• The employee communicates frequently with Altasciences employees across Canada and the United States. As such, English is the main language used to correspond between offices.
• The employee frequently communicates with English-only customers outside the province of Quebec.

What We Offer

The salary range estimated for this position is $82,000 - $136,000. Please note that salaries vary within the range based on factors including, but not limited to, prior relevant experience, skills, education, certification, location as well as internal equity and market data. Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences' Benefits Package Includes:

• Health/Dental/Vision Insurance Plans
• 401(k)/RRSP with Employer Match
• Paid Vacation and Holidays
• Paid Sick and Bereavement Leave
• Employee Assistance & Telehealth Programs

Altasciences' Incentive Programs Include:

• Training & Development Programs
• Employee Referral Bonus Program

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