Clinical Research Coordinator Part TIme

Benefits

Qualifications

• •2+ years of on-site CRC experience
• •Excellent working knowledge of medical and research terminology
• •Excellent working knowledge of federal regulations and good clinical practices (GCP)
• •Ability to communicate and work effectively with a diverse team of professionals
• •Excellent computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS Word, and Excel
• •Ability to work independently in a fast-paced environment with minimal supervision
• •Recent phlebotomy experience required
• •Additional Skills & Qualifications
• •5 more items(s)

Responsibilities

• •The Clinical Research Coordinator (CRC) position delivers strong customer experience for both sites and patients by providing onsite or remote study support under the delegation of a Principal Investigator (PI)
• •The CRC is responsible for study coordination, including study start-up, patient recruitment, backup support, and other duties as required to support the clinical trial and site
• •This is an onsite, hourly, part-time role at approximately 24 hours a week
• •Prescreen study participants and obtain informed consent per standard operating procedures
• •Complete visit procedures in accordance with the protocol
• •Train others and complete basic clinical procedures, such as blood draws, vital signs, and ECGs
• •Review laboratory results, ECGs, and other test results for completeness and alert values, ensuring investigator review in a timely fashion
• •Discuss study medication, required procedures, eligibility criteria, and impact on office flow with Investigator and site staff
• •Prioritize activities with specific regard to protocol timelines
• •Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
• •Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives
• •Identify adverse events (AEs) and serious adverse events (SAEs) and promptly notify Principal Investigator and Sponsor where appropriate
• •Work under the supervision of the Principal Investigator(s), exercising excellent clinical judgment in patient monitoring and care
• •Request medical records of potential and current study participants
• •Record data legibly and enter in real-time on paper or e-source documents
• •Accurately record study medication inventory, medication dispensation, and patient compliance
• •Resolve data management queries and correct source data within sponsor provided timelines
• •Assist regulatory personnel with completion and filing of regulatory documents
• •Assist in the creation and review of source documents
• •Assist with planning and creation of appropriate recruitment materials
• •Assist in the development of a recruitment plan and obtain a listing of potential candidates to contact from the subject database
• •Actively work with the recruitment team in calling and recruiting subjects
• •Recruit study patients by contacting subjects from the database and potential volunteers via phone, email, or post, and document contact accordingly
• •Review and assess protocol, including amendments, for clarity and logistical feasibility
• •Ensure that all training and study requirements are met prior to trial conduct
• •Communicate clearly verbally and in writing
• •Attend Investigator meetings as required
• •Ensure adequate supplies have arrived on site for protocol initiation, including lab kits, study medication, and specialized equipment
• •Interact in a positive, professional manner with patients, sponsor representatives, investigators, personnel, and management
• •Maintain effective relationships with study participants and other personnel
• •27 more items(s)