Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs to assess the safety and efficacy of investigational products and/or medical devices
Conduct site visits to determine protocol and regulatory compliance, and prepare required documentation
Develop collaborative relationships with investigative sites, and study vendors
Provide protocol and related study training to assigned clinical study sites
Attend disease indication and/or project specific training, as required
The RN Study Coordinator is accountable for the coordination and delivery of nursing care, including direct patient care, research participant/family education in clinical and research settings.
Responsibilities
Coordinate and deliver nursing care
Provide direct patient care
Educate research participants and families
Design, organize, and monitor protocols
Assist with grant applications, abstracts, posters, and manuscripts
Provide technical leadership and day‑to‑day management for a laboratory team, develop and validate analytical methods, oversee operations, and contribute to knowledge sharing within the research community.
Compensation
An industry competitive salary and benefits package, including company bonus.
Responsibilities
Provide technical leadership and day‑to‑day management for a laboratory team
Line manage up to 3 Laboratory Research Scientists
Collaborate with technical experts and cross‑functional teams to develop, validate and implement analytical methods
Oversee operational aspects of the laboratory area, including coordination of third‑party contractors
Ensure laboratory activities comply with safety, quality and compliance standards
Requirements
PhD in a relevant scientific discipline such as Microbiology or Molecular Biology
Nice to have: experience in host‑microbe‑nutrition interactions
Nice to have: experience working with low biomass samples
Lead scientific activities for clinical research programs supporting product development, regulatory approvals, post‑market evidence generation, and scientific communication.
Compensation
The base pay for this position is $78,000.00 – $156,000.00
Responsibilities
Lead development of clinical study protocols, protocol amendments, investigator brochures, case report forms, statistical assumptions, endpoint strategies, and clinical study reports.
Design prospective clinical studies, registries, observational studies, post‑market studies, and evidence‑generation programs supporting global regulatory and business objectives.
Serve as scientific lead for assigned clinical studies and provide strategic scientific direction throughout study planning, execution, analysis, and reporting.
Develop scientific rationale supporting study design, endpoint selection, evidence‑generation strategies, and clinical development plans.
Collaborate with biostatistics to review statistical analysis plans and interpret primary, secondary, subgroup, sensitivity, and safety analyses.
Requirements
Bachelor's degree in Life Sciences, Biological Sciences, Biomedical Sciences, Biomedical Engineering, Bioengineering, Public Health, Epidemiology, Nursing, Medicine, Pharmacy, or related scientific discipline.
Act as the lead programmer on selected studies of moderate complexity, working directly with project team leaders and client representatives to assess and develop project goals and timelines
Independently create, execute, maintain, and validate programs that transfer data across multiple data management systems or operating systems, combine data from a variety of sources and structures, generate and store summary data from a variety of sources, generate reports or combine multiple databases and validate programs that generate listings, tables and figures using SAS
Manage and document assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits
Increase knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry
Provide training and guidance to junior team members
Requirements
MS/MA degree in computer science, statistics, biostatistics, mathematics or related field
Bachelor's degree in computer science, statistics, biostatistics, mathematics or related field or equivalent and relevant formal academic / vocational qualification
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