PSG Global Solutions
Clinical Research Associate
Real Life Sciences' dedicated pharmaceutical and biotechnology division has been working with pharmaceutical companies, biotechnology organizations, and professionals across both sectors since 1998 and has focused on providing added-value recruitment services for companies working within development phases 1 to 4. We work with large multinational companies, generics and biosimilar manufacturers, small niche biotech organizations, and all parts of the pharma and biotech supply chain, including R&D companies, clinical research organizations, manufacturing companies, marketing and medical communications agencies, and regulatory affairs consultancies. Real Life Sciences' success within pharma and biotech recruitment is based on our ability to understand our key markets and develop a business that is focused on supporting our customers as their challenges change and the industry evolves. Job Description
Position Summary: Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays, and biomarkers developed by Ventana Medical Systems. Works closely with study managers and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring, and closing study conduct in accordance with the principles of Good Clinical Practice (GCP). Essential Functions: Conducts in-house monitoring, and may independently perform on-site monitoring in accordance with Roche and Ventana Standard Operating Procedures, ICH GCP guidelines, and Regulations. Participates in assessing study risks. Communicates on behalf of the study manager with investigators and site staff. Prepares study performance reports and provides input into study budgets. Study Implementation: Assists in preparation and independent execution of: Study training presentations for investigators and site staff. Study supply ordering and shipping. Investigational product release, labeling, accountability at study sites. Site Readiness and Site Monitoring Plans. Assay transfer and assay qualification activities. Study records including site and trial master files. Site qualification, site initiation, routine monitoring, and close out visits and reports. Document compilation for clinical study reports and document archive activities. Data management activities including user acceptance testing, data entry, and data verification as needed. Departmental Roles: Works within project teams to facilitate the conduct of standard study designs. Participates in clinical affairs meetings and completes independent activities to support departmental functions. Completes all internal training programs in a timely manner, and demonstrates professional development via independent reading, networking, and training. Adopts clinical practices that promote Quality First Time. Qualifications
Formal Training/Education: Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience. Experience: 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience required or equivalent combination of education and experience. Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred. A background in biomedical/healthcare services with laboratory experience preferred. Knowledge, Skills and Abilities: Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint). Excellent writing and verbal communication skills. Well organized and detail oriented. Impeccable record keeping and filing skills. Excellent time management skills. Ability to give presentations and teach others. Ability to work effectively in a team, and also work independently on assigned tasks. Ability to complete intermittent overnight travel up to 30%.
Real Life Sciences' dedicated pharmaceutical and biotechnology division has been working with pharmaceutical companies, biotechnology organizations, and professionals across both sectors since 1998 and has focused on providing added-value recruitment services for companies working within development phases 1 to 4. We work with large multinational companies, generics and biosimilar manufacturers, small niche biotech organizations, and all parts of the pharma and biotech supply chain, including R&D companies, clinical research organizations, manufacturing companies, marketing and medical communications agencies, and regulatory affairs consultancies. Real Life Sciences' success within pharma and biotech recruitment is based on our ability to understand our key markets and develop a business that is focused on supporting our customers as their challenges change and the industry evolves. Job Description
Position Summary: Responsible for the conduct of clinical study activities to verify and validate new instrument platforms, assays, and biomarkers developed by Ventana Medical Systems. Works closely with study managers and other CRA staff to complete all CRA functions associated with study planning, implementation, monitoring, and closing study conduct in accordance with the principles of Good Clinical Practice (GCP). Essential Functions: Conducts in-house monitoring, and may independently perform on-site monitoring in accordance with Roche and Ventana Standard Operating Procedures, ICH GCP guidelines, and Regulations. Participates in assessing study risks. Communicates on behalf of the study manager with investigators and site staff. Prepares study performance reports and provides input into study budgets. Study Implementation: Assists in preparation and independent execution of: Study training presentations for investigators and site staff. Study supply ordering and shipping. Investigational product release, labeling, accountability at study sites. Site Readiness and Site Monitoring Plans. Assay transfer and assay qualification activities. Study records including site and trial master files. Site qualification, site initiation, routine monitoring, and close out visits and reports. Document compilation for clinical study reports and document archive activities. Data management activities including user acceptance testing, data entry, and data verification as needed. Departmental Roles: Works within project teams to facilitate the conduct of standard study designs. Participates in clinical affairs meetings and completes independent activities to support departmental functions. Completes all internal training programs in a timely manner, and demonstrates professional development via independent reading, networking, and training. Adopts clinical practices that promote Quality First Time. Qualifications
Formal Training/Education: Bachelor of Science, RN, or BSN; OR equivalent combination of education and experience. Experience: 2+ years of previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or clinical study management experience required or equivalent combination of education and experience. Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) preferred. A background in biomedical/healthcare services with laboratory experience preferred. Knowledge, Skills and Abilities: Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint). Excellent writing and verbal communication skills. Well organized and detail oriented. Impeccable record keeping and filing skills. Excellent time management skills. Ability to give presentations and teach others. Ability to work effectively in a team, and also work independently on assigned tasks. Ability to complete intermittent overnight travel up to 30%.