Clinical Research Associate I (2023)

Qpex Biopharma is seeking a motivated Clinical Research Associate I 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 I (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:

Under the supervision of the Clinical Trials Manager, the Clinical Research Associate I (CRA I) is responsible for conducting all aspects of site monitoring for clinical research.

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.
• Retrieve, file, and maintain essential regulatory documents from the CRO and the clinical trial sites for the Trial Master File (TMF). Uploads to internal drives, Veeva, and SharePoint.
• Partners with the Clinical Operations Lead, CTM, and other in-house CRAs in the collection, review, and tracking of essential documents to ensure completeness of both site files and eTMF.
• Participates in clinical team meetings.
• Assists CTM and CRA II with the reviews of essential and non-essential documents and study plans to ensure accuracy and completion. Documents include but are not limited to: eCRFs, UAT in Medrio and RAVE, PMP, SAP, LDTAs, etc.
• Acts as bioanalytical subject matter expert and assists Non-Clinical & Clinical Development department heads with vendor management and ensures proper collection, storage, and shipment of laboratory specimens.
• Assists in updating of synopses, protocols and other study materials for Phase I studies.
• Assists in the development of pharmacokinetics manuals, pharmacy manuals, patient informed consents.
• Assists in the reviews of data tables, listings, and clinical study reports for assigned protocol(s).
• Assists in the review of proposals and budgets from a number of vendors, i.e., potential CROs, bioanalytical labs, pharmaceutical development services, etc.
• Works with Clinical Team in the management of Investigational Product (IP) at clinical sites.
• Manages inventory of clinical supplies at assigned sites and monitors the documentation of returns/destruction as appropriate.

Requirements

• A Bachelor's degree or higher in biological science, pharmacy, or other related discipline, or related laboratory skills is required.
• Experience/training in the following areas: GCP Regulations, ICH Guidelines, Good Quality Practices, 21CFR, HIPAA, Drug Development and Approval Process.
• Excellent interpersonal, verbal, and written communication skills, including experience in making presentations.
• Proficiency with Microsoft Office.
• Ability to perform virtual monitoring remotely, as needed.
• 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 incentive plan.

Attention: Search Firms/3rd Party Recruitment Agencies
The Qpex Biopharma human resources team manages the recruitment and employment process. To protect the interest of all parties involved, Qpex Biopharma will only accept resumes from a recruiter if an executed search agreement is in place at the start of the recruitment effort. Unsolicited resumes sent to Qpex Biopharma from recruiters do not constitute any type of relationship between the recruiter and Qpex Biopharma and do not obligate Qpex Biopharma to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.