Clinical Research Coordinator I

About the role

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high-quality data, and fully integrated research sites. As a Clinical Research Coordinator I, you will conduct and manage clinical trials in accordance with the study protocol, Good Clinical Practice (GCP), and Velocity’s Standard Operating Procedures (SOPs).

Responsibilities

• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity’s SOPs.
• Coordinate, with supervision, assigned clinical trials including start-up, vendor management, subject recruitment, source document review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner, and resolving queries.
• Manage and report adverse events, serious adverse events, and deviations; implement new protocol amendments and provide all close-out reports.
• 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.
• Ensure patient safety is upheld and 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 pre-screens.
• Execute recruitment strategies defined by the Clinical Research Team.
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope.
• Promote respect for cultural diversity and conventions with all individuals.

Qualifications

• Bachelor’s degree with 1 year of relevant experience in the life science industry OR
• Associate’s 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 of relevant experience in the life science industry.

Required Licenses/Certifications

• Phlebotomy if applicable and required by state law.
• Intramuscular dose administration and preparation if applicable and required by state law.

Skills

• Demonstrated knowledge of medical terminology.
• Demonstrated ability in the use of technology: computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Ability to work in a fast-paced environment.
• Strong verbal, written, and organizational skills.
• Strong interpersonal and communication skills.
• Ability to work as a team player.
• Ability to read, write, and speak English.
• Ability to multi-task.
• Ability to follow written guidelines.
• Ability to work independently, plan, and prioritize with some guidance.
• Flexibility/adaptability as daily schedules may change rapidly.
• Detail-oriented.
• Problem-solving and strategic decision-making ability.
• Ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued, and/or praised.

Physical Abilities

• Ability to sit or stand for long periods of time.
• Travel locally and nationally.
• Communicate in person and by telephone.
• Limited walking required.
• Limited to lifting up to 30 pounds.

Benefits

• Medical, dental, and vision insurance.
• Paid time off and company holidays.
• 401(k) retirement plan with company-match.
• Annual incentive program.