Site Specialist
About Avance Clinical:
Avance Clinical is a Contract Research Organization offering specialized services supporting drug development for the pharmaceutical and biotechnology industry.
We are currently seeking a Site Specialist to join our team!
Our ideal candidate is someone who has clinical experience, site level experience, someone who has worked directly with patient's!
Core Responsibilities
-Develop and maintain relationships with key opinion leaders, clinical investigators and relevant clinical research site personnel corresponding to the geographical location of their assigned responsibility across multiple therapeutic areas.
- Assess clinical trial feasibility through review of study information/materials provided by Avance’s clients.
- Provide clinical trial accrual projections through analysis of historical data and current trends in relevant clinical research and recommend geographical locations and clinical sites that can meet enrollment and study timeline objectives.
Activities include but are not limited to:
o Searches using subscription systems/databases (e.g. Trial Hub)
o Public database mining (e.g. PubMed, ClinicalTrials.gov)
o Support project specific investigator/site reach out and collection of relevant trial accrual and site capabilities data. Activities include but are not limited to:
o Prepare a study specific feasibility questionnaire.
o Review feasibility results and report on findings to stakeholders as required.
o Facilitate calls between sponsor and potential investigators.
o Liaise with project teams to evaluate status and progress of site identification, to identify and highlight any potential risks or issues to timelines or objectives.
o Maintain accurate and detailed documentation of site assessment processes, decisions, and communications.
o Prepare reports summarizing site selection activities and outcomes for management and cross-functional team reviews.
o Liaise with internal and external stakeholders, including clinical operations, scientific/regulatory affairs, clinical investigators and site coordinators, to gather and interpret data relevant to site selection.
o Ensure capture of strategy intelligence relating to clinical trial sites, investigators (e.g. performance in terms accrual, quality, compliance) in an appropriate software-based system (e.g. Veeva Vault).
o In conjunction with the Manager, plan and execute site-level feasibility analyses for awarded projects to support Clinical and Project Operations, as per activities outlined above.
o Ensure all site selection processes comply with regulatory standards and ethical guidelines.
Business Development Responsibilities
- Provide/present country and site level site feasibility analyses to support pre-award business development efforts including proposals and bid defense processes.
- Support effective project transition from BD to Operations in relation to site identification and selection.
Qualifications, Skills and Experience
- Bachelor’s level degree in life sciences, public health, nursing or related field.- - Industry experience in appropriate positions that complement the requirements of this position (including a minimum of 2 years’ experience in the biotech/pharma/CRO/trial site industry working in a GCP environment).
- Prior knowledge/experience in Oncology and CNS preferred.
- Knowledge of appropriate local regulatory guidelines and Ethics Committee requirements.
- Formal ICH GCP training and a working knowledge of ICH GCP Guidelines and other applicable regulatory requirements.