Job Description
Summary:
The Sub Investigator has responsibility for the clinical safety of the patients partaking in the clinical trial, collecting, and recording accurate clinical data while also ensuring that the well-being and interests of the subjects enrolled in the studies are being met. The Sub-I provides essential clinical support to the clinical research coordinators, principal investigators, and other clinical trials staff. Position is estimated to not exceed 10 hours a week.
Duties/Responsibilities
- Serve as leader of a study team to execute clinical trials
- Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
- Create training strategies and mitigation plans
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Eximia’s SOPs
- Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
- Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
- Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
- Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
- Ensure confidentiality of patient protected health information, sponsor confidential information and Eximia confidential information is maintained by all team members
- Develop communication and escalation strategies within teams to that ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Eximia SOPs
- Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
- Ensure staff are delegated and trained appropriately and documented
- Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
- Evaluate potential subjects for participation in clinical trials including phone and in person pre-screens.
- Create and execute recruitment strategies in conjunction with patient recruitment staff
- Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.
- Incorporate understanding of how decisions affect the bottom-line including links between operations and company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.
- Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
- Develop Quality Control strategies for team member projects
- Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
- Promote respect for cultural diversity and conventions with all individuals.
- Understand the disease process or condition under study
Required Skills/Abilities:
- Must be licensed as a MD, DO in the state you work in.
- Must undertake all training and certification required by sponsors and CRO’s to carry out clinical trials within specified timelines.
- Safe handling of data and records regarding privacy and confidentiality, per HIPAA
- requirements.
- Practices professionalism and integrity in all actions – Demonstrated ability to foster
- concepts of teamwork, cooperation, self- control, and flexibility to get the work done
- Ability to communicate effectively in English (both verbal and written).
- Up to 10% travel, as needed, for project team meetings, client presentations and other
- professional meetings/conferences as needed.
- Other duties as assigned.
Education and Experience:
- 5+ years of clinical experience or equivalent applicable experience in clinical research industry
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