Clinical Research Coordinator (Part TIme)
About the position Responsibilities • 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. Requirements • 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. • Bachelor's Degree preferred or equivalent combination of education, training, and experience. • Recent phlebotomy experience required. Nice-to-haves • Prior Nephrology experience is a plus. • Experience with Hepatology preferred. Benefits • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Apply tot his job