Altasciences
Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you're a recent college graduate or seeking your next career opportunity, it's time to discover your future at Altasciences.
We are better together and together We Are Altasciences.
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 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 and 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 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 No direct line 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) Experience in Phase 1 and Phase 2 clinical trials is preferred Previous CRO experience is preferred Certification in Clinical Research (e.g., CCRP, CCRA) 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 What We Offer 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
#LI-AN1
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
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!
We are better together and together We Are Altasciences.
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 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 and 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 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 No direct line 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) Experience in Phase 1 and Phase 2 clinical trials is preferred Previous CRO experience is preferred Certification in Clinical Research (e.g., CCRP, CCRA) 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 What We Offer 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
#LI-AN1
MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCH
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!