Lead Clinical Research Associate

CareAbout•Montreal, QC

9d•$82,000 - $136,000

About The Position

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.

Requirements

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
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.

Nice To Haves

Certification in Clinical Research (e.g., CCRP, CCRA) is preferred

Responsibilities

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.
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
Under the guidance of Clinical Monitoring Management, the Lead CRA will perform non-study activity in support of the overall Clinical Monitoring Team.
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