The Site Selection Specialist is a key collaborator to project teams as the main point of contact for site selection activities (including site identification and feasibility).
This role is perfect for you if:
- You have experience working with clinical research sites;
- You want to work in a collaborative environment;
- You want to have an impact in a fast-growing company.
RESPONSIBILITIES
More specifically, the Site Selection Specialist:
- Develops and maintains positive and productive relationships with key clinical research sites.
- Participates in the identification of investigators and research sites to expand the investigator database (e.g., performs literature/online searches to identify new investigators).
- Collects information supporting the definition of an ideal investigator for studies.
- Identifies and recommends potential investigators for studies.
- Develops interest survey assessments for studies.
- Creates and coordinates distribution of study-specific feasibility questionnaires.
- Reviews completed feasibility questionnaires and recommends sites for qualification visits.
- Coordinates CRA resource allocation required for site qualification visits.
- Reviews site qualification visit summaries.
- Recommends sites for participation in the study, in consultation with the Sponsor and other project team members (as necessary).
- Tracks key site selection activities in our Clinical Trial Management System (CTMS).
- Attends internal and external project team meetings, as necessary.
- Works in collaboration with project teams to identify quality issues related to sites performance on active studies through project meetings, escalation of site communications, and quality assurance audit findings.
- Participates in internal departmental projects initiated by the site selection and contracting group.
- May participate in internal departmental projects initiated by other groups to provide insight on site selection activities and overall site intelligence.
- Supports the Manager, Site Selection to ensure knowledge of the goals, scope and requirements of the internal and external projects and to ensure high quality results are delivered.
IDEAL PROFILE
- Bachelor’s degree in science or relevant field of study.
- Excellent oral and written skills in English, French is an asset.
- Minimum of 3 years of experience in clinical research in the biotechnology, pharmaceutical, or CRO industry, including significant and relevant experience in site selection, study start-up activities, site budget/contract negotiation and/or has worked closely with sites or worked in a site environment.
- Excellent knowledge of Microsoft Office suite (Word, Excel, Power Point).
- Experience of dermatological clinical research is an asset.
- Quick learner, good adaptability and versatile.
- Ability to work in a team environment and establish good relationships with colleagues, sponsors, and sites.
- Organized, able to juggle competing priorities, and work in a fast pace and evolving environment.
- Flexibility, positive attitude, superior attention to detail, and critical thinking skills.
- Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
Work location
Note that this opening is for a home-based position in Germany
About Indero
Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Germany.
Skills Required
- Bachelor's degree in science or a relevant field
- At least 3 years of clinical research experience in biotechnology, pharmaceutical, or CRO environments
- Significant relevant experience in site selection, study start-up, site budget or contract negotiation, or working closely with clinical research sites
- Excellent oral and written English skills
- Excellent knowledge of Microsoft Office, including Word, Excel, and PowerPoint
- Knowledge of Good Clinical Practice and applicable Health Canada and FDA regulations and guidelines
- Ability to work collaboratively and establish relationships with colleagues, sponsors, and research sites
- Strong organization, prioritization, adaptability, attention to detail, and critical-thinking skills
- French language skills
- Experience in dermatological clinical research
What We Do
As a CRO (Contract Research Organization) specialized in dermatology and rheumatology, we provide scientific guidance, accurate results and customer satisfaction. Our unique service offering combines specialized Contract Research Services, knowledge of dermatology sites in North America and Europe reach and the extended capabilities of a large clinical research site. The design and conduct of Phase I to Phase IV studies is our core expertise. Our specialized services include: • Study Design and Protocol Development • Submission to Regulatory Agencies and Central Ethics Committees • Regulatory Consulting • Trial Master Files Management • Project Management • Investigator / Site Selection • Patient Recruitment • Clinical Monitoring • Medical Monitoring • Pharmacovigilance • Data Management • Biostatistical Analysis • Clinical Study Report • Medical Writing / Publication Since 2000, Innovaderm has built a strong reputation for the quality of its research and the care offered to its study participants, its clients and its sites, often exceeding our client’s timeline expectations.
