The Clinical Research Specialist assists the Clinical Trial Monitor in planning and conducting OpGen’s clinical studies and data collection. He/she validates and interprets clinical data. She/he also oversees clinical monitoring, the conduct of the study, monitoring of regulatory standards, and the transfer of data. He/she participates in audits, in writing documents related to the study, and in developing reports on developments in clinical trials.
Essential Duties and Responsibilities
- Assists with preparation of all external and internal documentation, for OpGen clinical trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol.
- Assists Clinical Laboratory management in trial site management activities which could include review of monitoring report, tracking of site visits, communication with monitors and sites, and other activities as assigned
- Manages the study project plan, including timelines and budget.
- Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and Case Report Forms
- Serves as a liaison and resource for investigational sites.
- Maintains effective working relationships with site personnel
- Participates in the development, review and implementation of departmental SOPs and processes.
- Assists OpGen’s Lab Management in ensuring compliance with Clinical Study Protocol and provides timely updates to appropriate OpGen staff to confirm compliance
- Organizes and prepares study files and data and submits them to Bioinformatics team
- May participate in the training of CRO teams, investigators and staff as needed regarding assigned logistics of the clinical trial
- Proactively identifies potential study issues/risks and recommends/implements solutions
- Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates
Qualifications: Education and Experience:
- BA/BS degree in a science, technical or health-related field
- Experience working with scientists in any of these domains: PCR, antimicrobial resistance, microbiology, in-vitro diagnostics
- Experience with molecular diagnostics, genomics and whole genome sequencing preferred
- Experience working in clinical trials and interfacing with trial partners