Overview:
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Summary:
- The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Velocity’s SOPs.
Responsibilities:
Role & Responsibilities:
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelinesand 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 timelymanner and all queries are resolved, managing and reporting adverse events, serious adverseevents, and deviations, implementing new protocol amendments, providing all close outreports.
- Apply project management concepts to manage risk and improve quality in the conduct of aclinical research study
- Develop, coordinate, and implement research and administrative strategies to successfullymanage 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 tosponsor/CRO data capture systems and resolving queries
- Maintain confidentiality of patient protected health information, sponsor confidentialinformation and Velocity confidential information
- Verify and escalate patient safety concerns by ensuring all adverse events, serious adverseevents, and adverse events of special interest are followed and reported in accordance withthe protocol and Velocity SOPs.
- Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timelymanner
- Ensure staff are delegated and trained appropriately and documented
- Create, collect and submit regulatory documents to Sponsors and IRBs as required perprotocol, 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 eachassigned protocol.
- Understand product development lifecycle and significance of protocol design includingcritical data points
- 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
Qualifications:
Education/Experience:
- Bachelor’s degree and 2 years relevant experience in the life science industry OR
- Associate’s degree with 4 years relevant experience in the life science industry OR
- High School Graduate and/or technical degree with minimum of 6 years relevant experience in the
life science industry AND1 year Clinical Research Coordinator experience
Required Skills:
- Demonstrated knowledge of medical terminology
- Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Proficient ability to work in a fast-paced environment
- Proficient verbal, written, and organizational skills
- Proficient interpersonal and communication skills
- Proficient ability to work as a team player
- Profic