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
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.