Senior Clinical Research Associate

Pharma Medica Research Inc.; Toronto; Vor Ort; CAD 80.000 - 110.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Fully paid comprehensive benefits

Career progression opportunities

Employee milestones awards

Zusammenfassung

Pharma Medica Research Inc. (PMRI) is seeking a Sr. Clinical Research Associate to join our Scarborough team. The Sr.

CRA will monitor clinical trials at PMRI sites and external sites, ensuring compliance with GCP, protocol amendments, SOPs, and regulatory requirements. Reporting to the VP, Project Management, the role requires travel and a focus on protecting subject rights and data integrity. Eligible candidates should have a B.S.

Qualifikationen

• Bachelor of Sciences Degree is required.
• 5 years CRA experience in a CRO.
• Excellent knowledge of GCP.
• Excellent communication and interpersonal skills.
• Ability to work with minimum supervision.
• Detail oriented.

Aufgaben

• Monitor trials at PMRI facilities and external sites per GCP, protocol/amendments, SOPs and regulatory requirements.
• Protect rights and well-being of subjects.
• Perform Site Initiation Visits, Pre-Study Monitoring, On-Study Monitoring and Close-Out visits.
• Review source documentation for accuracy and compliance with GCP and protocol.
• Verify transcription of source docs to Case Report Forms (CRFs).
• Document visits in monitoring reports and follow up on corrective actions.
• Submit monitoring reports to site and Sponsor; communicate critical observations.

Kenntnisse

Communication

Attention to detail

Problem solving

Organization

Travel willingness

Ausbildung

Bachelor of Sciences Degree

Clinical research training

ACRP or SoCRA (asset)

Jobbeschreibung

Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people’s lives. Come join our team!

We are currently looking for a Sr. Clinical Research Associate to join our Scarborough Team!

The Sr. CRA (Clinical Research Associate) monitors clinical trials conducted at the Pharma Medica Research Inc. (PMRI) clinical facility and external clinical sites. This position reports to the VP, Project Management and/or designate.

This position is crucial in assuring that clinical trials conducted at PMRI clinical facility and external clinical sites are monitored effectively to ensure compliance Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements.

Since the task of monitoring is delegated by the Sponsor, this position acts on behalf of the Sponsor to ensure clinical trials are effectively monitored. Failure to do so effectively will have a negative impact on PMRI’s reputation as well as client and regulatory satisfaction.

Duties and Responsibilities

• Monitor clinical trials conducted at the PMRIclinical facility and external clinical sites for compliance with Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements.
• Ensure that the rights and well-being of subjects are protected.
• Perform Site Initiation Visits (SIV), Pre-Study Monitoring, On-Study Monitoring, and monitoring Close-Out visits.
• Review clinical trial source documentation for accuracy, completeness and compliance with Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements.
• Verify transcription of source documentation to Case Report Forms (CRFs).
• Document each monitoring visit in a monitoring report; follow-up and review site corrective actions to ensure effective resolution.
• Submit monitoring reports to the site and Sponsor.
• Ensure effective communication with the site and the Sponsor; ensure critical observations are immediately communicated to the site and Sponsor and effective resolution is obtained.
• Coordinate and host external Sponsor CRA on-site visits; ensure effective communication between the CRA and PMRI.
• Ability to travel.
• Other duties as required.

Requirements:

• Bachelor of Sciences Degree
• Additional education and training in clinical research.
• Recognized certification in clinical research (ACRP or SoCRA) is an asset.
• 5 years CRA working experience in a CRO.
• Excellent knowledge of GCP.
• Excellent communication and interpersonal skills.
• Ability to work with minimum supervision.
• Detailed oriented.
• Excellent problem solving and organizational skills.

We offer:

• Competitive compensation plan
• A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending and Wellness Spending Accounts and a voluntary RRSP Contribution Plan
• Opportunities for advancement and career progression
• A generous Employee Milestones Awards Program
• Corporate Discounts Program
• Learning Support Programs
• Friendly atmosphere, culture of learning

Please note all applications must be eligible to work within Canada.

PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.

We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.