Clinical Research Coordinator I

Clinical Research Coordinator I

The Clinical Research Coordinator I conducts and manages clinical trials in accordance with the study protocol, GCP, and Velocity's 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 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.
• 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 prescreens.
• Execute recruitment strategies defined by 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

Education/Experience:

• 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 minimum of 3 years 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

Required Skills:

• Demonstrated knowledge of medical terminology
• Demonstrated ability in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Demonstrated ability to work in a fast-paced environment
• 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 as daily schedule may change rapidly
• Must be detail oriented
• Demonstrated problem solving and strategic decision making ability.
• Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.

Required Physical Abilities:

• Sit or stand for long periods of time
• Travel locally and nationally
• Communicate in person and by a telephone
• Limited walking required
• Limited 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.