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$70k–$85k/yr
Full-time
high school, associate degree, bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Paid Time Off, Company Holidays, 401(k) Retirement Plan With Company-match
Posted 28d ago
Apply by Jul 13
~40 hrs/week
Responsibilities
Lead and manage clinical trial teams from start-up to close-out in accordance with protocols and GCP guidelines. Oversee subject recruitment, regulatory submissions, and the collection of high-quality clinical data.
Requirements
Requires a degree with 4 to 8 years of experience as a Clinical Research Coordinator depending on the education level. Must be able to obtain CCRP or SOCRA certification within six months of hire.
Full job description
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
Duties/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 manner and 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 escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol 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 product development life cycle and significance of protocol design including critical 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
Proficient ability to read, write, and speak English
Proficient ability to multi-task
Proficient ability to follow written guidelines
Proficient ability to work independently, plan and prioritize with minimal guidance
Proficient ability to be flexible/adapt as daily schedule may change rapidly
Must be detail oriented
Demonstrated problem solving and strategic decision making ability.
Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
Demonstrated leadership ability
Required Physical Abilities:
Sit or stand for long periods of timeTravel locally and nationally
Communicate in person and by a telephone
Limited walking requiredLimited to lifting up to 30 pounds
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
Compensation
Approximate range $30.00/hour to $36.00/hour. The base pay offered will be determined based on relevant factors such as experience, education, and geographic location.
Delivering high-quality clinical trial data and patient care with unprecedented efficiency.
Industry
Biotechnology Research
Company size
1,001-5,000 employees
Founded
2018
Headquarters
Durham, North Carolina
LinkedIn followers
40,464
Velocity is the world’s leading organization of fully integrated clinical research sites. With 70+ sites and 200+ investigators, Velocity partners with pharmaceutical and biotechnology companies to research new drugs, medical devices, diagnostics, and combination products that could improve human health and wellbeing. Velocity offers unified research site solutions to efficiently provide the right patients, investigators, and research staff for clinical trials across the U.S. and Europe. The company also operates a technology hub in India, where it is unlocking a new era in clinical research by developing innovative systems to leverage expansive site, patient, and historical performance data. To learn more about how Velocity delivers high-quality data, exemplary patient care, and unprecedented efficiency for clinical trials at any scale, visit VelocityClinical.com.
Offices: 300 E Main St, Durham, North Carolina 27701, US · 3121 Signature Ct, Medford, Oregon 97504, US · 911 E Hallandale Beach Blvd, Hallandale Beach, Florida 33009, US · 4260 Glendale Milford Rd, Cincinnati, Ohio 45242, US · 1900 Cypress Creek Rd, Suite 200, Cedar Park, Texas 78613, US
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