Sub Investigator

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.

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**:
**Responsibilities**:
**Duties/Responsibilities**
- Serve as leader of a study team to execute clinical trials
- Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
- Create training strategies and mitigation plans
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs
- Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
- Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
- Ensure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team members
- Develop communication and escalation strategies within teams to that 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
- Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
- Create and execute recruitment strategies in conjunction with patient recruitment staff
- Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.
- Incorporate understanding of how decisions affect the bottom-line including links between operations and company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.
- Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
- Develop Quality Control strategies for team member projects
- 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.
- Understand the disease process or condition under study
- Other duties as assigned

Qualifications:
**Required Skills/Abilities**:

- Must be licensed as a MD, DO, NP, or PA in the state you work in.
- Must undertake all training and certification required by sponsors and CRO’s to carry out clinical
trials within specified timelines.
- Safe handling of data and records regarding privacy and confidentiality, per HIPAA
requirements.
- Practices professionalism and integrity in all actions - Demonstrated ability to foster
concepts of teamwork, cooperation, self
- control, and flexibility to get the work done
- Ability to communicate effectively in English (both verbal and written).
- Up to 10% travel, as needed, for project team meetings, client presentations and other
professional meetings/conferences as needed.
- Other duties as assigned.

**Education and Experience**:

- Must be a licensed MD, DO, NP, or PA.
- 5+ years of clinical management experience or equivalent applicable experience in clinical
research industry

**Physical Requirements**:

- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
- Must be licensed as a MD, DO, NP, or PA in the state you work in.
- Must undertake all training and certification required by sponsors and CRO’s to carry out clinical
trials within specified timelines.
- Safe handling of data and records regarding privacy and confidentiality, per HIPAA
requirements.
- Practices professionalism and integrity in all actions - Demonstrated ability to foster
concepts of teamwork, cooperation, self
- control, and flexibility to get the work done
- Ability to communicate effectively in English (both verbal and written).
- Up to 10% travel, as needed, for project team meetings, client presentations and other
professional meetings/conferences as needed