Clinical Research Assistant 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.

Summary

• The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities.

Role & Responsibilities

• Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems.
• Prepare source document charts, copy and/or file medical records and study related documents as required.
• Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
• Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
• With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
• Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
• Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
• Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person
• Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
• Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
• Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity’s SOPs
• Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator
• Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team
• Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
• Enter source data into the sponsor's and/or vendor’s data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator
• Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team
• Other duties as assigned

Education/Experience

• High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences 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 ability to work as a team player
• Demonstrated ability to multi-task
• Demonstrated ability to follow written guidelines
• Understanding of verbal, written, and organizational skills
• Demonstrated ability to read, write, and speak English
• Demonstrated ability to use the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Demonstrated knowledge of medical terminology
• Demonstrated ability to be flexible/adapt as daily schedule may change rapidly

Required Physical Abilities

• Communicate in person and by a telephone
• Limited walking required
• Sit or stand for long periods of time
• Limited to lifting up to 30 pounds

Velocity is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. We are an E-Verify Employer in the United States.

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

• Provide medical expertise and scientific feasibility for new sponsor inquiries
• 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
• Oversee the administration of Investigational Product
• Ensure data collected at the study site is credible and accurate
• 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.
• Perform physical assessments, examinations and study procedures as required by study protocols
• Maintain trial documents as specified by guidelines and applicable regulatory requirements
• 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
• Assist and provide guidance to clinical operations, research staff, and to sponsor client managers as required
• Ensure accuracy, completeness, legibility, and timeliness of data reported and be consistent with source documents
• Review and adhere to study protocol
• Ensure that the safety and well-being of all participants in the study at the trial site are protected
• Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected
• Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities
• 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 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
• Be aware and comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements
• Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice
• 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
• Maintain proper documentation
• Evaluate and interpret clinical data and diagnostic information such as X-rays, ECGs and lab work.
• 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
• Ensure participants are informed and receive appropriate therapy and follow-up if the trial is prematurely terminated or suspended for any reason
• Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
• Obtain and/or review participants’ medical history

Required Skills/Abilities

• 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.
• Critical thinking, dynamic problem-solving skills, and attention to detail

Education and Experience

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

Role & Responsibilities

• Assist in the conduct of cl 12707