Clinical Research Associate II (2023)

Qpex Biopharma is seeking a motivated Clinical Research Associate II to join our dynamic development team. At Qpex Biopharma, we are dedicated to developing best-in-class agents to combat infectious diseases in both inpatient and outpatient settings. As a Clinical Research Associate II (2023), you will play a crucial role in supporting our clinical research efforts and contribute to the advancement of next-generation antibiotics.

As a company committed to diversity and inclusion, Qpex Biopharma values individuals who reflect our corporate culture, work ethic, and values. By joining our team, you will be part of important work that has the potential to redefine the conversation around infectious disease treatment.

Position Summary:

Accountable for managing the conduct and monitoring designated clinical trials and other related projects throughout the US and international locations in accordance with ICH guidelines, FDA Regulations and Company SOPs.

Responsible for oversight for clinical trials. This includes but is not limited to planning, organizing, and communicating with and managing sites to allow them to meet study objectives for study protocols.

Responsibilities include:

• Provides administrative support in accordance with FDA, ICH-GCP guidelines, applicable local regulations and SOPs for multiple Phase 1 clinical trials in anti-infectives from study start-up activities through completion of study.
• Provides CRA oversight for Qpex managed infectious disease clinical trials. This includes, but is not limited to, planning, organizing, and communicating with and managing sites to allow them to meet study objectives for Phase 1 SAD/MAD study protocols.
• Assists in the development and updating of synopses, protocols and other study materials for Phase I, II, and III studies.
• Prepares a variety of documents including protocols, CRFs, informed consent forms, operations manuals, and other documentation required for the conduct of a clinical trial.
• Reviews the TMF Plan and assists CRO in the creation and maintenance of the Trail Master File (TMF).
• Performs Trial Master File (TMF) reviews prior to, and after, TMF delivery from CRO.
• Updates trackers and GANTTs to assist with cost analysis, cost efficiency and timeline management of clinical trial project costs and tasks including clinical study budgets, pass-throughs, regulatory filing, IP shipments, data extracts, TLFs, deliverables from third party vendors, regulatory filings with FDA etc.
• Reviews site visit reports, confirmation letters, and follow-up letters written by contracted CRA(s) assigned to Phase I studies.
• Reviews essential and non-essential documents to ensure accuracy and completion. Documents include but are not limited to: eCRFs, UAT in Medrio and RAVE, PMP, SAP, LDTAs, etc.
• Participates in clinical team meetings; leads discussion on assigned protocol(s).
• Reviews data tables, listings, and study reports for assigned protocol(s).
• Responsible for writing RFPs (request for proposals) to a number of vendors, i.e. potential CROs, bioanalytical labs, pharmaceutical development services, etc.
• Responsible for reviewing proposals and potential budgets.
• Conducts and/or reviews pre-study site visits to assure adequacy of site, investigators, and research staff in accordance with SOPs and relevant regulations/guidelines. Recommends acceptable sites to study and management teams.
• Ensures continual availability, at each site, of clinical and non-clinical supplies necessary to meet study requirements.

Requirements

• A Bachelor's degree in relevant direction such as life science, medical or other related discipline or RN.
• A minimum of 2-4 years of experience directly supporting clinical research or similar experience in a medical/scientific area.
• In­-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
• Excellent interpersonal, verbal, and written communication skills, including experience in making presentations.
• Other requirements include willingness to work with multiple supervisors/colleagues in a matrix environment, and to value the importance of teamwork. Candidate must be able and willing to travel domestically and internationally 25% of the time and possess a valid driving license.

Benefits

An Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package including medical, dental, vision plans, LTD, paid vacation, and 401(k) plan.

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The Qpex Biopharma human resources team manages the