Clinical Research Coordinator

Thermo Fisher ScientificRichfield, MN
6h$26 - $30Onsite

About The Position

Join us as a Clinical Research Coordinator - And play a key role in overseeing clinical site activities and ensuring high standards of patient care and data integrity.

Requirements

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification
  • BLS certificate required.
  • Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
  • Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
  • Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
  • Demonstrated ability to exercise discretion and sound judgement
  • Good decision-making, negotiation and influencing skills
  • Good communication skills and English fluency will be an advantage
  • Good organizational skills
  • Good proficiency in basic computer applications
  • Good interpersonal skills to work in a team environment
  • Ability to work in an upright and /or stationary position for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
  • Frequent mobility required.
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
  • Regular and consistent attendance.

Responsibilities

  • Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines.
  • Provide medical care to patients, always ensuring patient safety comes first.
  • Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized.
  • Perform all defined study activities (i.e., informed consent, screening, and protocol procedures which include but are not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.).
  • Record all patient information and results from tests as per protocol on required forms.
  • Where required, may complete IP accountability logs and associated information.
  • Reports suspected non-compliance with relevant site staff.
  • Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
  • Promotes the company and builds a positive relationship with patients to ensure retention.
  • Attend site initiation meetings and all other relevant meetings to receive training on protocol.
  • May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
  • Logs/complete information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
  • Gather and maintain source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
  • Adhere to company COP/SCOP.
  • May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

Benefits

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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