Clinical Research Associate

4 weeks ago

Montréal, Canada 35Pharma Inc. Full time

**35Phama **is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of **Montréal, Canada**, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.

**Role**:
The **Clinical Research Associate** will be responsible for clinical monitoring activities at clinical sites to ensure compliance with the clinical protocol and study procedures, as well as all applicable regulations, guidelines, quality industry standards, internal standard operating procedures (SOPs) and policies. The Clinical Research Associate will be responsible to conduct on-site and remote monitoring visits, to review and collect sites essential documents required for the trial master file (TMF), and be the primary point of contact with sites for the protocol, recruitment status, and essential documents collection.

**Key Responsibilities**:

- Acts as primary point of contact for clinical sites for the conduct of the protocol.
- Supports the clinical sites with their patient recruitment initiatives and site-specific recruitment plans.
- Conducts on-site and remote monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, and site close-out visit).
- Prepares confirmation and follow-up letters to the investigators and monitoring visit reports.
- Participates in the preparation and review of study documents such as clinical protocol, informed consent form, laboratory manual, pharmacy manual, recruitment plan, etc.
- Participates in the planning and conduct of investigator’s meeting.
- Ensures review, collection, and tracking of sites essential documents as well as reconciliation with the TMF.
- Conducts co-monitoring visits with contract research organizations (CRO) or independent clinical research associates, as necessary.
- Supports the clinical sites during regulatory inspections and audits.
- Participates in the development of clinical monitoring SOPs, tools, and templates.
- May contribute to additional clinical operations activities as deemed necessary to ensure the clinical program success.

**Qualifications**:

- Bachelor’s degree in health sciences, nursing degree, or equivalent experience.
- Minimum of 2 years’ experience in a pharmaceutical or biotechnology company or CRO, in a clinical research associate role conducting on-site monitoring visits.
- Minimum of 5 years experience in a clinical monitoring, clinical trial management, or project management role in phase 1-3 multicenter clinical trials.
- Excellent interpersonal skills, strong written and verbal communication (French and English), and strong presentation skills necessary to meet the needs of various audiences.
- Ability to build effective relationships with site personnel, CRO and vendors staff, and colleagues.
- Superior problem solving, deductive reasoning and decision-making skills.
- Excellent time management and organizational skills, ability to prioritize tasks and accomplish set goals efficiently.
- Excellent attention to detail and ability to maintain detailed and accurate records.
- Ability to work independently.
- Excellent knowledge and understanding of the regulatory requirements and good clinical practices.
- Demonstration of the highest ethical standards, active promotion of trust, respect, and integrity.
- Proficiency in required softwares (Word, Excel, Power Point), clinical trial systems (i.e., EDC, eTMF, IRT, eCOA) and computer skills.
- Availability to travel frequently to clinical sites in Canada and the United States.

**Perks**:

- Comprehensive group insurance plan
- Paid public transit
- Beautiful office space in Montreal’s Old Port
- Onsite yoga and healthy snacks
- A team and culture committed to learning and high performance

**Contact**:
**Job Types**: Full-time, Permanent

**Benefits**:

- Commuter benefits
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- Paid time off
- Vision care
- Wellness program

Schedule:

- Monday to Friday

Application question(s):

- How many years of experience in a pharmaceutical, biotechnology company or CRO, in a clinical research associate role conducting on-site monitoring visits do you have?
- How many years of experience in a clinical monitoring, clinical trial management, or project management role in phase 1-3 multicenter clinical trials do you have?

Work Location: In person

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