Description: Summarized Purpose:
Clinical Research Coordinator (CRC) to support an ongoing study with data entry, query resolution, and other CRC activities. The ideal candidate will have previous experience working as a CRC and demonstrate a strong collaborative approach. They should be diplomatic, agile, and adaptable, with strong interpersonal skills and an ability to work effectively and constructively with different stakeholders.
Essential Functions:
Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
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 and maintains 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.
Education and Experience:
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 2+ years ).
Knowledge, Skills and Abilities:
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
Custom Fields:
Name: CW Shift
Value: (***) Days (United States of America)
Name: Is a DEA Background Screen required for this position?
Value: No
Name: Time Type
Value: Full time