What are the responsibilities and job description for the Clinical Research Coordinator position at Vitalix Clinical?
Who we are
Vitalix Clinical specializes in Phase II-IV clinical trials. We collaborate with patients, investigators, and research sites to ensure access to high-quality trials for those who need them most. Partnering with pharmaceutical and biotech companies, we connect diverse patient populations across a variety of indications while specializing in the Central Nervous System (CNS). Our strong commitment to patient care, regulatory excellence, and data integrity positions us as leaders in the clinical trial space, leveraging tailored recruitment strategies to accelerate enrollment and deliver impactful results.
This position is in person at our newly renovated office in the heart of downtown Worcester—a new, welcoming space designed to support our growing team and provide an accessible hub for patients, staff, and partners. This location reflects our commitment to innovation, collaboration, and offering the best environment for advancing clinical research.
Job Summary:
The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical trials under the direction of the Principal Investigator (PI) and in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and study protocols. The CRC will play a crucial role in the recruitment, enrollment, and management of study participants, ensuring the timely and accurate collection of study data.
Key Responsibilities:
- Coordinate and oversee clinical trials from initiation to close-out, ensuring compliance with study protocols and regulatory guidelines.
- Screen, recruit, and enroll eligible study participants; obtain informed consent and ensure participant safety.
- Schedule and conduct study visits, assessments, and follow-ups with participants as outlined in the protocol.
- Collect, document, and maintain accurate study data in electronic and/or paper source systems, ensuring data integrity and timely entry.
- Prepare and maintain regulatory documents (e.g., IRB submissions, consents, amendments) in compliance with regulatory agencies and study sponsors.
- Monitor participant safety, report adverse events, and ensure proper reporting and documentation of safety data.
- Collaborate with study sponsors, monitors, and regulatory bodies during audits and monitoring visits.
- Ensure proper handling, shipment, and storage of investigational products and study samples.
- Manage study budgets and ensure trial-related expenses are accurately tracked and reported.
- Train and educate research staff, interns, and other stakeholders on study protocols and procedures.
- Maintain patient confidentiality and ensure compliance with HIPAA regulations.
Qualifications:
- Bachelor’s degree in a health-related field (e.g., nursing, biology, public health) or equivalent experience.
- Ability to draw blood is a plus
- Experience in clinical research, ideally as a coordinator in clinical trials.
- Knowledge of GCP, FDA regulations, and ICH guidelines.
- Excellent organizational skills and attention to detail.
- Strong communication and interpersonal skills for working with patients, sponsors, and the research team.
Additional Requirements:
- Ability to work with a team and manage multiple projects simultaneously.
- Flexibility to work with diverse patient populations.
- Strong problem-solving skills and ability to work in a fast-paced environment.
- Willingness to stay updated on current industry practices and regulations.