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PPD

Sr Clinical Research Coord ; AES

  • Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
  • Provides medical care to patients, always ensuring patient safety comes first.
  • 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.
  • Attends 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 source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
  • Adheres 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.
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • Basic 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
  • Adequate decision-making, negotiation and influencing skills
  • Decent communication skills and English fluency will be an advantage
  • Decent organizational skills
  • Essential proficiency in basic computer applications
  • Decent interpersonal skills to work in a team environment

Job Qualification

Qualifications - External

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years’). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • Basic 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
  • Adequate decision-making, negotiation and influencing skills
  • Decent communication skills and English fluency will be an advantage
  • Decent organizational skills
  • Essential proficiency in basic computer applications
  • Decent interpersonal skills to work in a team environment

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