Sr. Clinical Research Associate

JOB SUMMARY:

Responsible for coordinating all phases of the company’s clinical trials to ensure that current GCP practices of the clinical studies, and that patient safety, regulatory compliance, required documentation, reporting specifications, and established company standards are met. This includes travel for clinical site monitoring of assigned trials. This position would travel ~50% of the time. There will be heavy focus on Site Activation and Site Management for this role.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES:

  • Acts as the main line of communication between the sponsor and the investigator.
  • Verifies that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout duration of clinical trials.
  • Ensures safety, compliance and proper conduct throughout the trial.
  • Verifies that the investigator follows the approved protocol and all GCP procedures.
  • Participates in investigator recruitment activities including identification and contacting of potential investigators; conducts pre-study site visits to assess the willingness and suitability of potential clinical sites.
  • Schedules and conducts on-site initiation, monitoring and close-out visits during clinical studies as indicated, ensuring adherence to the study protocol, accurate data collection and adherence to all local, national and U.S. Food and Drug Administration (FDA) regulations and international regulations, where applicable, pertaining to the clinical study of human subjects, according to Good Clinical Practices (GCP) and International Conference on Harmonisation (ICH) guidelines and OncoSec SOPs.
  • Manages clinical and regulatory tasks related to Clinical Research Organization (CRO).
  • Prepares and submits written reports of all site monitoring visits in a timely fashion according to Federal regulations and OncoSec SOPs.
  • Provides on-site training in the appropriate use of OncoSec’s products and equipment in preparation for patient treatments.
  • Tracks patient accrual, screening and enrollment information from sites. Promotes patient enrollment at clinical sites as needed to achieve enrollment projections.
  • Assists in the preparation of interim analyses, clinical study reports, annual reports and other clinical documents as needed.
  •  Other duties as assigned.

EDUCATION/EXPERIENCE/SKILLS:

  • Bachelor’s degree in life sciences or other field related to human study. An equivalent combination of education and applicable job experience may be considered.
  • Minimum of 5 years’ experience in a combination of the following:
    • Experience with administrative support within a Clinical Development & Operations department
    • Experience in the pharmaceutical/biotech or medical device industry
    • Experience in oncology desirable.
    • Basic understanding of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies, clinical protocols, investigator brochures and other materials.
    • Familiarity with all aspects of clinical trials including on-site monitoring experience.
    • Knowledge and CFR guidelines

MUST POSSESS:

  • Ability to work independently and in a team environment.
  • Excellent time management, project management, organizational, and communication skills (written and verbal) in local language and English
  • Expertise in and excellent working knowledge of core systems and tools
  • Skills and judgment required to be a good steward/decision maker for the company.
  • Excellent working knowledge of all applicable ICH/GCP regulations
  • Preferred candidate will reside within the territory.
  • Excellent verbal and written communication skills.
  • Computer literacy mandatory with proficiency in Microsoft Word, Excel, Project and Outlook.
  • Ability to coordinate and plan budgets and people utilizing time management skills
  • Ability to recognize potential obstacles and work to resolve them within set timelines
  • Conscientious and precise delivery of work even when under pressure
  • Able to manage multiple timelines and projects

JOB SCOPE:

Uses professional experience and concepts, applies company policies and procedures to resolve routine issues. Works on problems of limited scope following standard practices and procedures to analyze situations or data. Normally receives detailed instructions on all work.

ADA REQUIREMENTS:

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear in a standard office environment. In a lab setting, occasionally use hands to finger, handle objects, tools, or controls. Employee must occasionally lift and/or move up to 20 pounds.

———-

To apply, email your resume and cover letter to careers@oncosec.com.  In the subject line of your email, please enter the exact name of the position for which you’re applying.

OPEN POSITIONS
COMPANY BENEFITS