The Clinical Research Coordinator (CRC) is involved in. most aspects of each clinical trial, including the design, development, execution, and initial interpretation of clinical trials.
Clinical Research Coordinator job details
Quality of Life Research Centers is one of Tucson’s leading clinical research facilities. By way of achievement, we are proud to have been the number one enrolling site in Moderna’s COVID 19 vaccine trials. We provide a collegial atmosphere where individuals can learn and grow and be proud of their achievements and their impact on the public health.
The Clinical Research Coordinator (CRC) is involved in. most aspects of each clinical trial, including the design, development, execution, and initial interpretation of clinical trials. The CRC has direct involvement with study participants, Principal and Sub-Investigators, recruiters, etc. and may assist with team coordination, communication, training, and quality control. The CRC also helps develop standard operating procedures, compliance forms, and tracking documents.
Duties & Responsibilities
- 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, create source documents, update patient files and notes, always ensuring relevant and most up-to-date information is recorded.
- Adheres to company SOP’s.
- 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
- Ability to exercise discretion and sound judgment
- Excellent decision-making, negotiation, and influencing skills
- Excellent organizational skills
- Excellent interpersonal skills to work in a team environment
- Bachelor’s degree or equivalent advanced learning attained through experience required.
- Excellence and Consistency
- A Spirit of Collaboration and Innovation
- Respect for our Subjects, Sponsors and Team Members
- Respect for our Community
- Unimpeachable Ethics
Quality of Life Research Centers offers a highly competitive benefits package, including:
- Health Insurance
- Dental and vision
- Paid Time off
- 401K with employer match.
- Paid Holiday’s
- Continuing education reimbursement