Velocity Clinical Research, Inc. stands as a premier integrated research site organization that is deeply committed to delivering quality patient care and producing high-standard clinical data. With the mission to provide innovative medical treatments to patients, Velocity has built a reputation for excellence and reliability. The company focuses on making clinical trials successful by swiftly generating high-quality data from a wide range of patients while ensuring top-tier patient care at every step. For employees, Velocity offers a growth-driven environment where high performers are recognized and rewarded, fostering an ideal space for career advancement in the life sciences field.
Responsibilities in the Job
As a Specialist I, Study Build, you will play a crucial role in preparing and maintaining accurate source material for the setup and successful delivery of clinical research studies. Key responsibilities include:
- Conducting initial reviews and creating comprehensive study documentation to support timely study delivery and expedited start-up.
- Ensuring the timely setup of source documents to prevent delays in study initiation.
- Adhering to a multi-step process to maintain data source integrity.
- Notifying the site-level team upon the completion of source setup.
- Reviewing and understanding study protocols and other relevant materials.
- Supporting new site acquisitions to ensure standardized source practices.
- Managing multiple systems and source formats efficiently.
- Assisting new hires with research documentation and training requirements.
- Communicating updates on amendments or changes to study sources with both site-level staff and the internal source team.
- Following safety and compliance guidelines and regulations.
- Performing additional duties as assigned.
Qualifications
Candidates must meet the following educational and experience requirements:
- Bachelor’s Degree with at least 1 year of relevant experience in the life sciences industry, OR
- Associate Degree with at least 2 years of relevant experience in the life sciences industry, OR
- High School Diploma or a technical degree with a minimum of 3 years of relevant experience in the life sciences industry.
Skills
Successful candidates for this role should demonstrate:
- Knowledge of medical terminology.
- Proficiency in using computers and Microsoft Office Suite.
- Strong verbal, written, and organizational skills.
- Effective interpersonal and communication abilities.
- Team collaboration and independent work capabilities.
- Fluency in reading, writing, and speaking English.
- Multi-tasking ability and adherence to written guidelines.
- Flexibility and adaptability to meet clinic priorities.
- Attention to detail and accountability for personal performance.
- Familiarity with ICH, GCP, and FDA regulatory standards.
Physical Requirements
The role may involve:
- Extended periods of desk work and computer usage.
- Communication in person and via phone.
- Occasional walking and the ability to lift up to 30 pounds.
