Primary Responsibilities

• Conduct site monitoring visits (qualification and selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol, study specific documents and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol while maintaining adherence to applicable regulations and escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, diary and survey data and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Act as a mentor for clinical staff including conducting co-monitoring and training sign-off compliance visits
• Collaborate with study team members for project execution support as appropriate.
• May be accountable for supporting development of project subject recruitment plan on a per site basis
• May be accountable for site financial management according to executed clinical trial agreement and manage invoices according to local requirement

Requirements

• Bachelor’s Degree in scientific discipline or health care preferred.
• Requires at least 4 years of year of on-site monitoring experience.
• Equivalent combination of education, training and experience considered.
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. MedTech regulations and active experience preferred.
• Strong therapeutic and protocol knowledge as provided in company training.
• ICU/CCU nursing background.
• CKRT/CRRT experience is desirable.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and mobile technology required.
• Written and verbal communication skills including command of English language.
• Organizational and pragmatic problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with co-workers, managers, sponsor staff and sites

Behaviours

• Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Supervisory Responsibilities

• This position will have supervisory responsibilities.