Clinical and Health - Clinical Research Coord II

Mindlance

Bowie, MDFull-time

Behavioral Health Market Context

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Qualifications

  • •Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
  • •Must hold a valid nursing license (RN, LVN, LPN) within the country operating
  • •Must be registered with local health care authority
  • •Previous experience that provides 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
  • •9 more items(s)

Responsibilities

  • •Study coordinator to support ongoing large clinical study in US
  • •Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process
  • •Interacts with the research site team and other interdepartmental staff
  • •Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution
  • •Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines
  • •Provides medical care to patients, always ensuring patient safety comes first
  • •Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized
  • •Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.)
  • •Records 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 to 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
  • •ttends 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/completes 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
  • •Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded
  • •dheres 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
  • •16 more items(s)
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