Job Description

Job Description

Job description

Position Overview

Our rapidly expanding team is seeking a  Lead Clinical Research Associate (LCRA)who can work for us on a full-time basis at Guelph, ON location.

The LCRA will work closely with the Director of Program Management in the oversight, growth and development of the clinical monitoring team. Additionally, the LCRA will work closely with the Project Management Team and Leads of the CRO teams to ensure the successful execution of the clinical trials.

LCRA is responsible for oversight of all 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

Primary Responsibilities:

The Lead Clinical Research Associate will include, but is not limited to:

· Manages, Trains and mentors CRA I, CRA II and CRA III with emphasis on teamwork, quality, timelines, budget, metrics and compliance with the project plans and SOPs

· Develops the strategy, plans, tools and training to oversee and assess performance of the CRA team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: Pre-Site Selection Visits (PSSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), Remote Monitoring Visits (RMVs), Motivational Visits, Close-out Visits (COVs), and Audit support Visits

· Responsible for developing CRA monitoring metrics, site logs and tools, performs protocol and trip report review, provides team training, prepares study-specific PSSV, SIV, IMV, COV report templates, and creates study-specific Clinical Monitoring Plans (CMPs) while managing the clinical operations (monitoring) budget for each project

· Reviews the content and quality of site monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct; ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines

· Assists the PM in contract negotiations with site Investigators; provides input on and reviews contract issues as needed

· Proactively communicates with CRAs and other members of the clinical operations team to follow up on all open issues and drive patient recruitment and retention, in order to meet the project timelines

· In coordination with the Project Manager, oversees monitoring activity coordination to ensure the study is conducted in compliance with applicable procedures and regulations, to meet the expectations/objectives/deliverables identified for the study

· Participates in/attends periodic meetings with clients, project management and investigational sites as needed to discuss study progress, issues that sites have encountered, etc.

· Identifies, evaluates, and recommends potential investigators/sites on an on-going basis to assist in the placement of planned clinical studies with qualified investigators

· Anticipates and proactively solves study site problems/issues as they occur and initiates, recommends, and communicates corrective actions as needed

· Proactively communicates and escalates with all internal and external stakeholders any issues identified at investigational sites while developing the corresponding mitigation actions and solutions and recommended approach

· Participates in TMF and onsite audits as requested

· Escalates issues in a timely manner and works with Quality Assurance and the project team on Corrective and Preventative Actions, as applicable

Core Competencies

· Minimum of BS/BA degree in a health-related field

• Minimum 2 years’ experience as a Lead CRA or an equivalent combination of education and experience in a CRO or Pharmaceutical setting
• Minimum 5 years CRA experience, on-site or in-house
• Ability to travel ~20% of time to domestic and international destinations
• Comprehensive knowledge of clinical study conduct and ICH GCP
• Knowledge in the field of natural health products and pharmaceuticals
• Excellent interpersonal skills
• Good working knowledge of medical terminology, physiology, and pharmacology in multiple therapeutic areas
• Strong communication, organizational and planning skills
• Strong computer skills with demonstrated experience in working with Microsoft Office programs (Word, Excel, PowerPoint, and Outlook)

· Ability to work in a team setting

· Strong problem solving and analytical skills

Job Type: Full-time

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