Clinical Research Coordinator II: Drive High-Quality Trials

Velocity Clinical Research, Inc.; Plymouth; On-site; GBP 28,000 - 42,000; Full time

Job summary

Velocity Clinical Research, Inc. is seeking a Clinic Research Coordinator II to oversee multiple trials from start-up through close-out in accordance with the protocol, GCP, and company SOPs. This on-site role in Plymouth requires meticulous data handling and participant safety oversight.

The coordinate will manage start-up activities, site QC, subject recruitment, regulatory submissions, and vendor relationships while collaborating with sponsors, CROs, and our clinical research team.

Qualifications

• Bachelor’s degree and 2 years relevant life sciences experience.
• Associate’s degree with 4 years relevant experience.
• High school graduate with 6 years relevant experience in life sciences and 1 year Clinical Research Coordinator experience

Responsibilities

• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs
• Implement and coordinate assigned clinical trials including start up, vendor management,subject recruitment, source development review, scheduling subjects, protocol training,collection of regulatory documents, conducting visits, ensuring data is entered in a timely mannerand all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
• Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors.
• Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
• Verify and escape patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with theprotocol and Velocity SOPs.
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
• Ensure staff are delegated and trained appropriately and documented
• Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
• Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
• Create and execute recruitment strategies defined by Clinical Research Team
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• Understand the disease process or condition under study
• Collaborate with Clinical Research Team to develop Quality Control strategy for reviewingone’s work on an ongoing basis and in preparation for monitor visits.
• Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG,lab processing) within scope
• Other duties as assigned

Skills

Medical terminology

Professional communication

Team player

English proficiency

Organizational skills

Problem solving

Education

Bachelor’s degree in life sciences or related field

Associate’s degree with 4+ years life sciences experience

High school diploma with 6+ years life sciences experience

Tools

MS Office

Computers

Data entry systems

Fax and copier

Job description

Velocity Clinical Research, Inc. is seeking a Clinic Research Coordinator II to oversee multiple trials from start-up through close-out in accordance with the protocol, GCP, and company SOPs. This on-site role in Plymouth requires meticulous data handling and participant safety oversight.

The coordinate will manage start-up activities, site QC, subject recruitment, regulatory submissions, and vendor relationships while collaborating with sponsors, CROs, and our clinical research team.