Manager, Clinical Site Jobs

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.

Job Summary

The Manager, Site Operations is responsible for managing the clinical operations staff, training and onboarding of new staff, managing quality and compliance of clinical Work closely with and in support of the Site Director. Able to perform coordinator as well as supervisor duties and fill in during the absence of site coordinators. Able to function as lead coordinator on select protocols. Must be able to work independently and with all staff and customer levels.

Duties/Responsibilities

• Manage the performance of site staff members, delegating appropriate and challenging assignments to encourage growth, development and responsibility. Responsible for supporting the ongoing training needs of site staff members are met.
• Work with the Site Director to address any study and/or clinical quality related matters.
• Support the identification of strategies to expand the research capabilities at the site - in line with the overall site business plan.
• Support business development activities on behalf of the site and VCR with sponsors, CROs,CRAs and any third-party study vendors, as appropriate.
• Communicate performance expectations and guidelines to site staff members.
• Support or lead the development of the patient recruitment plan and patient outreach process for studies. Make ongoing adjustments/modifications to recruitment strategies based upon the timely review of results to ensure study-specific targets are being met.
• Support the completeness, accuracy and timeliness of Feasibility Questionnaires, CDAs, CVs and essential regulatory documents from study start-up phase until site initiation.
• Share best practices with other VCR site locations with the goal of raising the overall level of operational competencies at VCR.
• Identify and manage issues, concerns and problems related to staff conduct and performance.
• Support the implementation and maintenance of VCR quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs.
• Identify and build relationships with outside medical practices, pharmacies, and other healthcare professionals/organizations to aid in the patient recruitment process.
• Ensure timely and appropriate communications occur with Sponsors and IRBs as necessary.
• Work with the Site Director to meet/exceed the site’s financial, operational and study-specific targets.
• Attend industry and VCR meetings relevant to the position of Manager, Site Operations.
• Manage facility and IT needs to ensure smooth and efficient operations
• Support the development of site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies.

Required Skills/Abilities

• Extensive knowledge of clinical research
• Able to generate business correspondence, create forms and generate reports as required
• Ability to communicate effectively in English (both verbal and written)
• Practices professionalism and integrity in all actions
• Expertise in project management
• Knowledge of field organizational strategies
• Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
• Strong communication and presentation skills
• 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

• Bachelor’s degree preferred; Advanced degree suggested or equivalent clinical research experience.
• 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.

NOTE The above 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

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 Principal Investigator responsibilities are centered around the execution, planning and management of assigned studies. Communicate succinctly with clients, study directors and technicians are key as is a cross-functional, flexible, and collaborative spirit. The Principal Investigator is responsible for the conduct of the clinical trial at a trial site

Duties/Responsibilities

• Maintain trial documents as specified by guidelines and applicable regulatory requirements
• Evaluate and interpret clinical data and diagnostic information such as X-rays, ECGs and lab work.
• Provide medical expertise and scientific feasibility for new sponsor inquiries
• Obtain and/or review participants’ medical history
• Ensure that the safety and well-being of all participants in the study at the trial site are protected
• Prior to starting a study and while a study is ongoing, ensure that the study, clinical trial protocol, informed consent form, recruitment materials, and other documents provided to the subject are approved by the IRB and comply with GCP (Good Clinical Practices) and other regulatory requirements as required.
• Ensure that the IRB is provided with a copy of the Investigator’s brochure, product monograph, or information about the product or intervention to be studied so the IRB can fully assess the risks involved
• During the study, ensure the IRB is informed of any changes to the protocol, Investigator’s brochure (or other safety information about the product/intervention), protocol deviations, or unanticipated problems
• Ensure accuracy, completeness, legibility, and timeliness of data reported and be consistent with source documents
• Inform and provide a detailed written explanation of the termination/suspension of the trial to the IRB and, if the investigator terminates the trial without prior agreement, to the study sponsor
• Ensure data collected at the study site is credible and accurate
• Ensure retention of essential documents until at least two years after the last approval of a marketing application or at least two years since formal discontinuation of the investigational product
• Perform physical assessments, examinations and study procedures as required by study protocols
• Assist and provide guidance to clinical operations, research staff, and to sponsor client managers as required
• Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected
• Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice
• Review and adhere to study protocol
• Be aware and comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements
• Maintain proper documentation
• Immediately report Serious Adverse Events (SAEs)—or any abnormalities affecting participants’ safety—to sponsors and to the IRB as required by study specific reporting guidelines
• Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities
• Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
• Oversee the administration of Investigational Product
• Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator’s brochure/product monograph and other documents provided by the sponsor
• Ensure participants are informed and receive appropriate therapy and follow-up if the trial is prematurely terminated or suspended for any reason

Required Skills/Abilities

• Critical thinking, dynamic problem-solving skills, and attention to detail
• Ability to travel for work related purposes (Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.)
• The ability to communicate effectively in a flexible and collaborative manner
• Understanding of regulatory requirements, principles of GCP and biomedical research ethics.

Education and Experience

• Board certification or board eligibility in a specialty appropriate to the type of research being conducted at the site.
• Training and certification in Good Clinical Practice (GCP)
• Minimum qualifications include an M.D or D.O with an active medical license (medical license must be valid in the state in which the research is conducted).
• Training and certification in Velocity required trainings and Standard Operating Procedures (SOP’s).
• Medical licensure (license must be valid in the state in which the research is conducted).

Duties/Responsibilities

• Work with the Site Director to addr 12707
• Support the identification of strategies to expand the research capabilities at the site - in line with the overall site business plan.
• Support the implementation and maintenance of VCR quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs.
• Work with the Site Director to meet/exceed the site’s financial, operational and study-specific targets.