Clinical and Health - Clinical Research Coord II

Job-ID29299050Reference26-25826Summarized 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.”