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)
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