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 RoleResponsible for the day to day management of a team of both permanent Clinical Research Associates and contract Clinical Research Associates, overseeing their performance and training, ensuring adequate monitoring resources, allocating resources to projects, identifying quality issues related to clinical monitoring activities and establishing action plans to address them.
What You'll Do Here- Ensures that clinical monitoring activities of their assigned team are performed to the Sponsor's satisfaction, ensuring timely quality deliverables, within budget and in accordance with applicable standard operating procedures (SOPs regulations, good clinical practices and study-specific requirements).
- Provides expertise, strong leadership and management.
- Serves as a point of contact for CRAs and other team members for assigned projects or initiatives
- Ensure projects/studies are resourced appropriately by allocating or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of assigned staff.
- Tracks clinical monitoring metrics such as number of site visits performed, utilization, and timeliness to complete deliverables such as site visit report finalization, follow-up letters, timesheets, expense reports and required trainings
- Provides quality Oversight - Reviews trip reports and manages any issues brought to attention by CRA staff and/or the study team and/or Sponsor. Oversees Corrective Actions/ Preventive Actions (CAPAs) of assigned staff to ensure timely and sufficient resolution.
- Conducts Monitoring Oversight Visits
- May conduct on-site monitoring visits to offer support to project teams
- Identifies and implements professional development and performance evaluations
- Continuously and proactively identifies and proposes solutions for process improvement opportunities to the Director of Monitoring Services and communicates best practices to monitoring staff.
- Serves as a management contact for sites, project teams, and sponsors when issues related to clinical monitoring and trial management activities must be escalated to ensure communication is maintained and resolution is achieved
- May review and provide feedback on related SOPs.
What You'll Need to Succeed- Minimum of 6 years of clinically-related experience, of which a period of 3 years is preferable in clinical research monitoring or equivalent experience.
- Bachelor's or equivalent health related (e.g., Medical, Scientific, Nursing) degree preferred.
- Knowledge of clinical research industry, terminology and practices.
- Knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Strong verbal and written communication skills.
- Familiarity with EDC systems; ability to learn required systems quickly and to train others, especially site staff.
- Ability to meet deadlines, multitasks, and prioritize based on study needs.
- Ability to make sound decisions based on available information.
- Ability to establish and maintain a good working relationship with site personnel/ colleagues.
- Ability to work both in a team and independently.
- Ability to facilitate team meetings and teleconferences.
- Ability to present at internal study team meeting(s).
- Proficient with Microsoft Office Word, Excel and Power Point.
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Ability to work on site as needed.
- Ability to travel.
What We Offer The pay range estimated for this position is $115,000 - $135,000 yearly. Please note that hourly rates/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
- Telework when applicable
Altasciences' Incentive Programs Include: - Training & Development Programs
- Employee Referral Bonus Program
- Annual Performance Reviews
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MOVING IN UNISON TO DELIVER A BIG IMPACT WITH A PERSONAL TOUCHAltasciences 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!
