Study Startup Specialist - Research Innovation & Discovery

About the Opportunity

The Study Start-Up Specialist is an effective planner and problem solver who provides direct support to investigators and their teams during the clinical study start-up phase. The Study Start-Up Specialist will guide and support multiple administrative activities (e.g., contracting, REB submissions, etc) as required by the assigned clinical research group. The Study Start-Up Specialist will be expected to independently manage multiple study and site level deliverables during the study start-up phase. They will also work the Research and Innovation team and stakeholders to develop institutional processes and will provide recommendations for ways in which these processes can be improved.

The Study Startup Specialist will provide strategic advisory support as needed to accelerate study startup processes, and the nature of Study Startup Specialist support will depend on the specifics of the team, sponsor, and opportunity. This role will be responsible for supporting Principal Investigators (PIs) during Feasibility Assessment, Site Selection Visit (SSV) and Site Initiation Visit (SIV). This role will maintain communication with Investigative sites, Sponsors, and Study Operations Team regarding the status of contracts and contract-related documents, prepare and oversee preparation of budget, contractual documents and correspondence, and facilitate the indemnification process between the study Sponsor and the site, and establishes, maintains, and delivers Sponsor/ CRO communication as well as actions, decisions, and issues, as required.

About You

We would love to hear from you if you have the following:

• Master’s Degree or minimum of 4 years related education and experience required
• Minimum 5 years experience in project management is considered a strong asset
• Minimum 5 years of experience in a senior administrative coordination role in a clinical research set-up is considered a strong asset
• Current knowledge of and the ability to apply ICH/GCP and all applicable regulations and guidelines
• Well versed on from local Health Authority and Ethics Committees requirements
• Leadership competencies including analytical thinking, action management, team leadership, initiative, collaboration, negotiation, persuasion, relationship building, and diversity proficiency and awareness
• Ability to develop project/process workflows
• Experienced in stakeholder engagement and alliance management
• Knowledge of the health sciences research enterprises in a university setting, particularly in relation to hospital-based research, and knowledge of the national research environment
• An in-depth knowledge and understanding of clinical research processes, regulations and methodology
• Competent in both written and verbal communication
• Experience working with diversity of staff and stakeholders, with knowledge of cultural competence, diversity, and social inclusion
• Ability to work closely and effectively with a diverse cross-functional group of administrators; strong interpersonal and leadership skills; proven ability to effect and influence change through collaborative and inclusive style
• Ability to anticipate needs, respond accordingly, provides guidance and support
• Sound knowledge of information systems

Please ensure your resume is up to date and includes all relevant education, experience, training, and certifications.

Hours

Permanent, Full-Time / 75 Hours Bi-Weekly

Compensation and Benefits

$38.36 - $47.95 Hourly

Successful candidates may be eligible for our benefits package which includes health, dental, travel, long-term disability, and life insurance coverage as well as a defined benefit pension plan.