Clinical Research Intern

Koning Corporation is hiring a Clinical research intern.
Koning Corporation is the inventor of the world’s first true 3D Breast CT scanner for early breast cancer detection and diagnosis.  With FDA approval and over 80 patents globally, Koning has recently won the Frost & Sullivan “New Product Innovation Award” for the Breast imaging industry in 2016.  We are now on the journey to bring 3D Breast CT scanners globally and improve women’s health everywhere.

Summary Of Position With General Responsibilities

The Clinical Research Intern (CRI) supports the day to day operations associated with the execution of clinical trials. He / she will provide support and monitoring for multiple clinical trial sites and studies. The primary objective and purpose of this position is to ensure the overall quality of clinical trials by supporting the collection of and monitoring study data and managing site adherence to the protocol, GCP, all applicable regulations and related study documents. In conjunction with the Corporate Clinical Affairs Department, the CRI is a primary contact with the field staff and study site and serves as a liaison between clinical investigators and Koning. He / she is responsible for site training, regulatory document collection, tracking enrollment, and ensuring case report forms are accurate, complete and verifiable against source documents. The CRI will also assume project management responsibilities as required.

Upon successful completion of a 6 month internship; the candidate is eligible to receive a full-time offer.

Essential Job Functions:

  • Assist in development of protocol, ICF, CRF, CRF completion guidelines, preparation and maintenance of monitoring plans, study binders, study manuals, and other site specific and monitoring tools
  • Request and collect initial regulatory documentation
  • Ensure that sites fulfill their regulatory obligations and submit study documents for IRB review and approval
  • Perform study tracking and reports progress in a timely manner;
  • Plan and conduct training, site initiation, interim and close-out visits. Complete timely and accurate trip reports
  • Track and account for study devices; assess and monitor that investigational devices are available, appropriately used, handled correctly, stored, and accurately inventoried and documented
  • Monitor data and follow up with sites regarding timely completion and retrieval of CRFs and data correction forms
  • Assist sites to resolve regulatory document issues; ensure adequate study and regulatory documentation is maintained at the both the investigator site and Koning;
  • Verify appropriate reporting and documentation of adverse device events, protocol deviations and subject enrollment
  • Communicate findings from contact reports and monitoring visits to Senior Manager and/or Project Manager in a timely manner
  • Initiate and track payments to study sites and external vendors as necessary
  • Build research reports and translate findings into marketable white papers for clinicians and hospitals

Basic Qualifications:

  • Experience in monitoring clinical study data and managing site-related issues
  • Knowledge of study protocols and case report forms, trial abstracts, and clinical publications
  • Thorough understanding of operational aspects of clinical research and regulatory requirements
  • Good interpersonal, problem solving and communication skills
  • Excellent follow-through capability
  • Attention to detail and organizational skill
  • Able to work with little supervision; must be a self-starter.
  • Possesses working knowledge of computer/PC skills with experience in Microsoft Word, Excel, Access, Microsoft Project and PowerPoint, network systems (electronic mail) and Clinical Trial Management Systems

Education And/or Experience:

  • BS/ BA or higher in a related scientific area preferred;
  • Experience conducting clinical studies in medical device or pharmaceutical industry. Knowledge of and experience in the hospital environment.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear. The employee will sometimes be required to move around in manufacturing facility or meet with medical professionals in a hospital environment. Specific vision abilities required by this job include close vision and color vision.

Employee is required to meet with other personnel in other areas of the building.

Work Environment:

  • This position is in an office environment.
  • No special work environment conditions other than minimal exposure to manufacturing environment (i.e noise, minimal heat and some chemical fume exposure), laboratory, and hospital settings.
  • Travel will be required.

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