Reporting to the Director, Clinical Operations, the Clinical Research Associate (CRA) oversees the conduct of assigned clinical studies including acting as liaison to clinical investigators & ensuring the quality and integrity of data. The CRA will independently perform clinical monitoring activities to ensure site compliance and adherence with study protocols, project plans, Jennerex SOPs, and FDA/ICH GCP regulations.

 Responsibilities include but are not limited to:

• Conduct Site Qualification, Site Initiation, Interim Monitoring, Site Close-out, and other study-specific visits including the completion of trip reports and follow-up letters after each visit


• Verify that the investigator has adequate qualifications and resources including facilities, laboratories, equipment, and staff to safely and properly conduct the trial.  Confirms that qualifications and resources remain adequate throughout the trial period


• Ensure the collection and maintenance of required essential documents and ensure these documents are delivered to the Trial Master File


• Ensuring the sites are adequately prepared and trained to participate in the clinical trial


• Ensure that the investigator receives the current Investigator’s Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s)


• Verify investigational product is handled according to the regulations


• Report site status to the Lead CRA/Project Manager and develop a patient recruitment plan in conjunction with the site and Lead CRA


• Verify that the investigator provides all the required reports, notifications, applications, and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial


• Determine whether all adverse events (AEs) are appropriately reported within the time periods required by Good Clinical Practices (GCP), the protocol, the Ethic Committees (IRB/IEC), the sponsor, and the applicable regulatory requirement(s)


• Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations


• Maintain current, accurate and complete tracking tools and provide status updates including essential documents, monitoring visits, CRF collection, data entry, query status, SAE reporting, subject screening and recruitment, supplies inventory, and overall project timelines and budgets.


• Prepare essential document packages for sites and review the completed site essential document packages for accuracy, completeness, and compliance with GCP. Ensure site essential documents are up to date, working with the CRA to collect documents from sites.


• Maintain and ensure quality of the Trial Master File including tracking, review of documents and filing.


• As needed, the CRA will assist the Project Managers in the implementation of clinical projects by gathering information concerning therapeutic areas; reviewing protocol synopses and protocols; assisting in the generation of study specific case report forms, source documents and other study tools; identifying investigators and assessing their suitability; assisting in the management of clinical trial medications and supplies; interacting with service providers; scheduling and documenting team meetings, and assisting investigative sites with regulatory documentation.

 Qualifications:

• BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent experience


• 5 years on-site monitoring experience


• Oncology background or experience is preferred


• Ability to travel approximately 25% travel based on study demands


• Good working knowledge of GCP/ICH Guidelines and all monitoring responsibilities


• Formal certification as a Certified Clinical Research Associate (CCRA) is highly desirable


• Effective written communication skills and computer skills are required

The CRA must possess the ability to work closely with all disciplines within a small company, displaying innovative thinking, a strong sense of responsibility and accountability, and integrity.. 

Salary:

Title and competitive compensation package commensurate with experience

Please submit your resume to: HR@Jennerex.com

Your resume is very important to us. In order to process your resume in the most efficient manner possible, Jennerex strongly encourages you to apply online. It is not necessary to send a back-up hard copy resume. Thank you for your cooperation with our process and, most importantly, your interest in Jennerex