Lead Clinical Research Associate

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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 youre a recent college graduate or seeking your next career opportunity its 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 Youll 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 Youll Need to Succeed

• Bachelors 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 $82000 - $136000. 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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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!

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 82000 - 136000