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Clinical Study Monitor

Minneapolis, MN

Posted: 04/05/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2321

As a Clinical Study Monitor, you will work within a clinical team setting to ensure study compliance with protocol, FDA and ICH guidelines.

JOB RESPONSIBILITIES:
  • Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures.
  • Adhere to monitoring plan protocols; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates.
  • Monitor clinical trial progress through a combination of data review and on-site monitoring visits.
  • Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review).
  • Independently coordinate ongoing and upcoming monitoring assignments
  • Meet expected timelines for completion of monitoring activities and submission of written monitoring reports.
  • May assist in the development and writing of clinical trial monitoring plans.
  • May provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
  • Participate in regular monitoring team group meetings.
  • May assist with CRA in-house site related responsibilities
  • May participate in Clinical Operations Committees

REQUIREMENTS / QUALIFICATIONS:
  • Bachelor’ s degree in a related health profession or nursing
  • 2+ years of oncology monitoring experience required
  • Knowledge of FDA regulatory requirements, ICH guidelines, GCP, and commonly used study processes
  • Proficient in RDE, CTMS, Excel and MS Word
  • Experience with data listing and patient profile review is a plus.
  • Ability to work effectively in teams as well as independently
  • Strong verbal and written communication skills
  • Ability to prioritize and manage multiple tasks and responsibilities
  • Excellent communication skills, both oral and written
  • May be home or office based depending on location
  • National Travel: Approximately 50 – 60%

 

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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