Study Start-up Specialist

7 months ago

Halifax, Canada Nova Scotia Health Authority Full time

**Req ID: 160486**
**Company: Nova Scotia Health**
**Location: Central Zone, Centre for Clinical Research - QEII**
**Department: RSH Director Research AH**
**Type of Employment: Permanent Hourly FT (100% FTE) x 1 position(s)**
**Status**:Management/Non Union Position**
**Posting Closing Date: 31-Jul-23**

Nova Scotia Health is the largest provider of health services in Nova Scotia, with some specialized services also offered to clients throughout Atlantic Canada. We’re on a mission to achieve excellence in health, healing and learning through working together, which is reflected in the hospitals, health centres and community-based programs we operate across the province. Our passionate team of professionals provides a variety of high-quality inpatient and outpatient services including academic, tertiary, and quaternary care, as well as continuing care, primary health care, public health, and mental health and addictions. Join a diverse team of innovators, collaborators and creative thinkers today.

Nova Scotia Health’s Research, Innovation and Discovery portfolio is transforming health care delivery and improving the health of all Nova Scotians by leading initiatives that deliver high-impact health care solutions and developing strategic partnerships with clinical champions, industry, healthcare foundations, governments and academic partners. By pairing leading researchers, innovators, and clinicians with entrepreneurs through our newly formed Nova Scotia Health Innovation Hub, their creative solutions are improving health and health care while also contributing directly to Nova Scotia’s economy_._

**About The Position**:
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.

**Qualifications**:

- 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
- 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.

**Responsibilities**:
Primary responsibilities of this roles include, but are not limited to:

- Developing and implementing internal study start-up processes and procedures. Oversees their continuous improvement
- Working with

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