Clinical Research Sub Investigator - 257742

Job Description

We are seeking a licensed nurse practitioner or physician assistant who has previous clinical research experience for a full time clinical research sub investigator opportunity.

Our client runs a growing nationwide clinical research network conducting industry-sponsored clinical trials across a wide range of therapeutic areas. Their West Des Moines, Iowa site conducts clinical research in areas including metabolic disease, neurology, cardiovascular conditions, vaccines, and other chronic and acute conditions. They provide comprehensive operational, regulatory, recruitment, and clinical support, focusing strongly on patient safety, data quality, and successful study execution.

Job Description:

The Sub-Investigator is responsible for the clinical safety of patients participating in clinical trials, collecting and recording accurate clinical data, and ensuring that the well-being and interests of study subjects are protected. The Sub-Investigator provides essential clinical support to Clinical Research Coordinators, Principal Investigators, and other clinical trial staff.

Position: Part-time or Full Time

Duties & Responsibilities

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• Serve as a leader of a study team to execute clinical trials.
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• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills.
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• Create training strategies and mitigation plans.
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• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH guidelines, and Eximia's SOPs.
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• Implement and coordinate assigned clinical trials, including:
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• Study start-up
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• Vendor management
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• Subject recruitment
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• Source development and review
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• Subject scheduling
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• Protocol training
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• Collection of regulatory documents
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• Conducting study visits
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• Ensuring data is entered in a timely manner
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• Ensuring all queries are resolved
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• Managing and reporting adverse events (AEs), serious adverse events (SAEs), and protocol deviations
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• Implementing new protocol amendments
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• Providing all study close-out reports
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• Apply project management concepts to manage risk and improve quality in the conduct of clinical research studies.
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• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
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• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
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• 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.
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• Ensure confidentiality of patients' protected health information, sponsor confidential information, and Eximia confidential information is maintained by all team members.
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• Develop communication and escalation strategies within teams to ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are appropriately followed and reported in accordance with the protocol and Eximia SOPs.
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• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner.
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• Ensure staff are appropriately delegated and trained, and that documentation is maintained.
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• Ensure the creation, collection, and submission of regulatory documents to sponsors and IRBs as required by the protocol, GCP/ICH regulations, and IRB requirements.
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• Evaluate potential subjects for participation in clinical trials, including phone and in-person pre-screens.
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• Create and execute recruitment strategies in conjunction with patient recruitment staff.
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• Incorporate key timelines, endpoints, required vendors, and patient population considerations when planning for each assigned protocol.
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• Understand how operational decisions affect the company's financial performance and recognize the importance of creating value for all organizational stakeholders when planning for each assigned protocol.
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• Incorporate an understanding of the product development lifecycle and the significance of protocol design, including critical data points, when planning for each assigned protocol.
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• Develop quality control strategies for team projects.
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• Perform clinical duties, such as drug preparation and administration, FibroScan, phlebotomy, ECGs, and laboratory processing, within the scope of practice.
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• Promote respect for cultural diversity and conventions with all individuals.
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• Understand the disease process or condition under study.
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Required Skills & Abilities

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• Must be licensed as an MD, DO, NP, or PA in the state in which you work.
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• Must complete all training and certifications required by sponsors and CROs to conduct clinical trials within specified timelines.
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• Demonstrate safe handling of data and records regarding privacy and confidentiality in accordance with HIPAA requirements.
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• Demonstrate professionalism and integrity in all actions, with the ability to foster teamwork, cooperation, self-control, and flexibility to accomplish work effectively.
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• Ability to communicate effectively in English, both verbally and in writing.
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• Up to 10% travel, as needed, for project team meetings, client presentations, professional meetings, conferences, and other business-related activities.
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• Perform other duties as assigned.
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Education & Experience

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• Must be a licensed MD, DO, NP, or PA.
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• 5+ years of clinical experience or equivalent applicable experience in the clinical research industry.
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