Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request. Join us at Altasciences!
Lead Clinical Research Associate
Location
Canada
Posted
13 days ago
Salary
$82K - $136K / year
Seniority
Lead
No structured requirement data.
Job Description
Lead Clinical Research Associate
CareAbout
Role Description 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 - Support the planning, scheduling and tracking of visits - Oversee visit reporting as defined in the Clinical Monitoring Plan (CMP) - Collaborate with the Data Management team to oversee SDV progress, query resolution, and timely data processing by the CRAs - Develop the Clinical Monitoring Plan, including risk identification and mitigation strategies - Prepare and provide training material (e.g., Site Initiation Visit / Investigator Meeting slides), as needed - Review 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 - Update tracking systems - Collect clinical monitoring metrics - Ensure 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, perform 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 - Prepare and deliver training and presentations - Act as a mentor for new Clinical Monitoring team members (e.g., CRA, LCRA), by providing guidance, support and training (initial and ongoing) - Contribute to departmental SOP and process development and revision, and the implementation of systems - Participate in audit preparation, conduct and follow-up activities, as needed - Participate in CAPA implementation, as needed - Review study documents, as needed (e.g., protocol, ICF…) - Other non-study activities, as requested by Clinical Monitoring Management Qualifications - 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 Requirements - Fluency in English is an essential requirement for the position of Lead Clinical Research Associate - 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 - The employee frequently communicates with English-only customers outside the province of Quebec Benefits - Health/Dental/Vision Insurance Plans - 401(k)/RRSP with Employer Match - Paid Vacation and Holidays - Paid Sick and Bereavement Leave - Employee Assistance & Telehealth Programs - Training & Development Programs - Employee Referral Bonus Program Company Description Altasciences is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability or any other protected grounds under applicable legislation. Reasonable accommodations for persons with disabilities during the recruitment process are available upon request.
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