Specialist I, Study Build

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.

Job Summary:

Prepare and maintain complete and accurate source material to support the setup and delivery of clinical research studies.

Duties/Responsibilities:

• Supports initial review, creation, and set up of study documentation to prepare source for timely study delivery with a focus on expedited study start-up.
• Ensures source documents are set up in a timely manner so as to not delay study start-up.
• Follows a multi-step procedure to ensure data source integrity.
• Ensures that the site-level team is aware when the source is set up and completed at the project level.
• Review and comprehend the protocol and any other supporting material or guidelines.
• Supports new sites in the process of acquisition to ensure harmonization in source.
• Demonstrates flexibility and willingness to work in multiple systems and manage sources in multiple formats.
• Assist new hires in completing and submitting all required research documentation and training by their deadlines.
• Communicate with site-level staff regarding amendments and changes to the source.
• Communicate internally with the source team regarding source status and changes to the source.
• Adhere to safety and compliance regulations.
• Other duties as assigned.

Required Skills/Abilities:

• Demonstrated knowledge of medical terminology
• Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Demonstrated verbal, written, and organizational skills.
• Demonstrated interpersonal and communication skills.
• Demonstrated ability to work as a team player.
• Demonstrated ability to read, write, and speak English.
• Demonstrated ability to multi-task.
• Demonstrated ability to follow written guidelines.
• Demonstrated ability to work independently, plan, and prioritize with some guidance.
• Demonstrated ability to be flexible/adapt according to the needs of the clinic's prioritization.
• Must be detail-oriented.
• Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued, and/or praised.
• Demonstrated understanding of ICH, GCP, and FDA regulatory requirements.

Education and Experience:

• Bachelor's degree with 1 year of relevant experience in the life science industry OR
• Associate degree with 2 years of relevant experience in the life science industry OR
• High School Graduate and/or technical degree with a minimum of 3 years relevant experience in the life science industry

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Communicate in person and by telephone.
• Limited walking required.
• Must be able to lift up to 30 pounds at times.

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.