Sub Investigator Job at Velocity Clinical Research, Inc., Portsmouth, VA

RUxOdm5hczhKK2pBamUvZmpUcmNPVDBzTkE9PQ==
  • Velocity Clinical Research, Inc.
  • Portsmouth, VA

Job Description

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.

Summary:

  • The Sub Investigator has responsibility for the clinical safety of the patients partaking in the clinical trial, collecting, and recording accurate clinical data while also ensuring that the well-being and interests of the subjects enrolled in the studies are being met. The Sub-I provides essential clinical support to the clinical research coordinators, principal investigators, and other clinical trials staff.
  • 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
  • Implement and coordinate 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.
  • Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
  • Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
  • Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
  • 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.
  • Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
  • 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

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.
  • 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.

Job Tags

Holiday work,

Similar Jobs

Stihl Inc

Planning Analyst Job Details | STIHL Job at Stihl Inc

 ...comprehensive service. STIHL is seeking a highly motivated Planning Analyst to join Team STIHL in our Virginia Beach, VA location! With...  ...and family members ~ Company Paid Short & Long-Term Disability ~ Company provided Life Insurance ~ Fully vested after 5... 

Biospan Careers Page

Private Chef for HNWI Client in Miami Job at Biospan Careers Page

 ...Are you a chef who wants to escape the toxic kitchen workplace and work directly with private clients? Join the movement to fight against the processed junk-food giants in favor of mighty organic, home-cooked meals - the fuel that made humans into the most successful... 

Marriott International

Events Manager Job at Marriott International

 ...Job Description JOB SUMMARY Responsible for preparing all event documentation and coordinates with Sales, property departments...  ...diploma or GED; experienced (1 - 2 years of experience) in the event management or related professional area. OR 2-year... 

The Swift Group

Junior Full Stack Developer Job at The Swift Group

 ...The Swift Group is looking for a Full-Stack Software Engineer to join a cutting-edge program that develops applications in an agile environment. Key Responsibilities: Provide bug fixes, enhancements, and Graphical User Interface (GUI) improvements to applications... 

State of Colorado

Compliance Investigator I - (Colorado Springs) Liquor Enforcement Division Job at State of Colorado

 ...Colorado public and to foster a clean, healthy community, in compliance with retail sale of tobacco and nicotine products. This position...  ...program in place. Liquor, Tobacco, and Criminal Code Investigations Plan and conduct investigations and follow-up investigations...