Clinical Research Coordinator (Part TIme)

Actalent•Newport News, VA

72d•$25 - $35•Hybrid

About The Position

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.

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.

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.