Clinical Research Associate

**Position Overview**

Our rapidly expanding team is seeking a **Clinical Research Associate (CRA)** who can work for us on a full-time basis at Guelph, ON location. CRA is responsible for monitoring activities at the clinical sites in compliance with the protocol, ICH-GCP guidelines, applicable Federal & Local regulations including company’s Standard Operating Procedures. You will be responsible for monitoring of single-center clinical trials in North America, including planning, organizing, and conducting monitoring visits in order to meet study objectives for protocols.

**Responsibilities**
- Maintain timely and effective communication among team members and site staff.
- Keep project leadership apprised of team issues, seeking guidance as needed.
- Assure compliance with CFR, State regulations, ICH and GCP guidelines and Nutrasource and sponsor SOPs.
- Maintain current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
- Participates in TMF and on-site audits as requested.
- Assume responsibility for site management and site staff performance including:

- Monitor all types of clinical trials.
- Participate in all types of site visits - Pre-Site Selection Visit (PSSV), Site Initiation Visit (SIV), Interim Monitoring Visit (IMV), Close Out Visit (COV), Remote Monitoring Visit (RMV)
- Assure Principal Investigator (PI) integrity and compliance with all protocol requirements.
- Assure effective patient identification and recruitment plan is in place.
- Assure timely reporting of AEs/ SAEs and Protocol Violations.
- Regularly perform Investigational Product (IP) accountability.
- Regularly review the status of contents of the site Regulatory Binder.
- Resolve problematic issues in a productive way.
- Exhibit effective time management skills.
- Perform observation visits with less experienced CRAs.
- Perform source document verification (SDV) according to contractual requirements.
- Assure timely completion and submission of CRFs according to Clinical Monitoring Plan

(CMP) and / or Data Management Plan (DMP).
- Assure timely and accurate completion of Data Clarification Forms (DCFs).
- Perform clinical data listings reviews as needed.
- Complete and submit visit reports according to SOP/WI or sponsor requirements and

requiring mínimal revisions.
- Maintain awareness of key study performance indicators for own sites, e.g. patient

enrollment, SAEs.
- Update study and patient status information and serves as (CTMS) resource for

PM/LCRA.
- Track Investigator payments/ milestones, if requested.
- Document and track the resolution of all outstanding site-specific protocol-related issues

from visit to visit.
- Prepare for and attend investigator’s meetings as requested. May present as requested.
- Assist with the preparation of study start up materials and tools, as requested.
- Attend clinical monitoring staff meetings, project team meetings, clinical committees,

and clinical training sessions according to the project Communication, Monitoring and /

or Training Plans.
- May assume Lead CRA role and/ or assist with LCRA activities, e.g., tool development, plans and other related activities

**Core Competencies**
- Requires comprehensive knowledge clinical study conduct and the ICH E.6 R2 regulations.
- Thorough knowledge of study SOPs
- Good working knowledge of medical terminology, physiology, and pharmacology in multiple therapeutic areas.
- Ability to travel ~60% of time.
- Strong communication, organizational and planning skills.
- Strong computer skills with demonstrated experience in working with Microsoft Office programs (Word, Excel, PowerPoint, and Outlook).
- String interpersonal skills
- Strong problem solving and analytical skills

**Qualifications**
- Bachelor’s degree in a health science field or nursing degree
- Preferred: Certified Clinical Research Professional (CCRP) by the Society of Clinical Research Associates (SOCRA) or equivalent and/or Certified Clinical Research Associate (CCRA) by the Association of Clinical Research Professionals (ACRP) or equivalent

Minimum of 2 years of experience of clinical trial and monitoring experience

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

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

**Benefits**:

- Dental care
- Extended health care
- Vision care

Schedule:

- 8 hour shift

Supplemental pay types:

- Bonus pay

Work Location: One location