Career Opportunity: Clinical Research Director
The Clinical Research Director (CRD) will report to the Vice President, Clinical and will be responsible for the direction, planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Supporting new and ongoing clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. Monitoring adherence to protocols and determine study completion. Managing clinical and regulatory files through CRO oversight. Interacts with investigational sites, clinical consultants, Contract Research Organizations (CROs) and other vendors ensuring completion of studies on time and on budget. This position will be office-based in our Devon, Pennsylvania office.
- Supports data analysis and assembly, including clinical study report writing, contribution to the preparation of abstracts, presentations, and manuscripts.
- Directs protocol implementation, including site identification and communication, attend investigators’ meetings, correspond with sites, and interact with operations teams.
- Ensures the feasibility of the study by incorporating study design elements that are ethical and consistent with standard of care and applicable local practices. Acts as support for development of clinical/scientific content for communications with regulatory agencies and IRBs/ethics boards.
- Ensures clinical data meets all necessary regulatory standards.
- Maintain project timelines to ensure that corporate objectives are met.
- Establishes and maintains appropriate collaborations with knowledge experts.
- Oversees and provides leadership to colleagues involved in clinical trial execution.
- Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws from FDA, EMA, and CHMP, as well as with Zynerba’s policies and procedures.
- Prepare and/or review protocol synopses, protocols and protocol amendments.
- Conduct study monitor and investigator training.
- Interact with investigators/study site personnel to resolve issues.
- Interview and assess capabilities of CROs and service vendors for specific clinical studies.
- Assist with the negotiation of contracts with CROs and investigators.
- Manage the activities of selected CRO(s) to ensure successful execution and completion of clinical trial activities.
- Manage the study budgets for CROs, investigator grants and other vendors, as applicable.
- Identify investigators and assess their suitability for participation in a Zynerba study.
- Interact with the Data Management, Biostatistics and IWRS companies and any other service providers applicable to managing the clinical study.
- Attend pre-study qualification, initiation, monitoring and close-out visits with CRO CRA staff, if appropriate.
- Conduct quality and safety review (under supervision of Medical Monitor) of completed CRFs to ensure appropriate reporting of adverse events and adherence to the protocol.
- Review the issued Clinical Study Report for a clinical study and provide information as needed.
- This position requires a minimum of a Bachelor’s Degree in a scientific discipline or pharmacy and a minimum of 5 years of experience as a Clinical Research Manager. Masters or PhD level training with experience in research design and analysis or clinical epidemiology preferred.
- Approximately 30% overnight travel, based on study demands, is required. Some international travel may be required.
- Possess a sound theoretical and hand’s-on knowledge of the field of clinical research inclusive of planning, executing and analyzing clinical research trials; performing protocol and site feasibility.
- Excellent Communications Skills, Excellent Interpersonal Skills – Ability to build and maintain strong working relationships across all levels of the organization. Must possess the ability to work closely with all disciplines within a small company.
- Must have a good working knowledge of GCP/ICH Guidelines and all monitoring responsibilities.
- Formal certification as a Certified Clinical Research Associate (CCRA) and previous project management experience is highly desirable.
- Must be able to work with minimal direction, be able to prioritize, and be capable of handling multiple assignments.
- Strong computer skills, MS Word, Excel, Outlook, MS Project and PowerPoint.
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