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.
In this position, you will be eligible for the following perks:
- Flexible work schedule
- Home-based position
- Ongoing learning and development
About Indero
A Global Clinical Leader In Dermatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
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 Romania.
Skills Required
- Bachelor’s degree in science or a relevant field of study
- Excellent oral and written English communication skills
- At least 3 years of clinical research experience in the biotechnology, pharmaceutical, or CRO industry
- Relevant experience in site selection, study start-up activities, site budget or contract negotiation, or working closely with clinical research sites
- Excellent knowledge of Microsoft Office, including Word, Excel, and PowerPoint
- Ability to work in a team environment and establish relationships with colleagues, sponsors, and sites
- Strong organization, prioritization, adaptability, attention to detail, and critical-thinking skills
- Knowledge of Good Clinical Practice and applicable Health Canada and FDA regulations and guidelines
- 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.
