Clinical Research Associate

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 Clinical Research Associate II (CRAII) will report to the Manager, Monitoring Services. The CRA II will perform monitoring and site management activities for clinical research projects to assess the progress of clinical projects at assigned investigative sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Clinical Monitoring Plan, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and/or all applicable local and federal regulatory requirements. This a hybrid position.

What You'll Do Here

• Complete Protocol and CMP training for all assigned projects.
• Identify investigators.
• Assist in the Creation of Clinical Monitoring Plans (CMP).
• Performs site qualification, initiation, interim monitoring, site management and close- out visits (on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and CMP.
• Assesses site processes.
• Conducts source documents review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report forms (CRFs) is accurate and complete via review of site source documents and medical records.
• Applies query resolution techniques (on-site or remotely) and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject as required/appropriate.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, and when applicable, compares its content to the Trial Master File (TMF) inventory list.
• Performs investigational products (IPs) inventory, reconciliation and reviews of storage conditions.
• Facilitate audits and audit resolution. Process and track (S)AEs.
• Review study protocols and Informed Consent forms.
• Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.

What You'll Need to Succeed

• Bachelor's or equivalent health related (e.g., Medical, Scientific, Nursing) degree preferred.
• Minimum of 2 years of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring or equivalent experience.
• 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 travel.

What We Offer

The pay range estimated for this position is $76,000 - $125,000 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 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!