COMPANY DESCRIPTION
Charter Research is a highly experienced and quickly growing clinical research company, based in Florida and Illinois, that is looking to add to our team to help us fulfill our mission of discovering future medicines. Our company is privately owned and prides itself on providing exceptional patient experience to our participants, as well as offering agile recruitment strategies to our sponsors. Above all, we are a team, and we are seeking the right team member to add to our foundation in The Villages, FL.
POSITION OVERVIEW
The Research Assistant (RA) is responsible for supporting the day-to-day operations of clinical trials designed to test the safety and effectiveness of new drugs. The RA provides support services for clinical research studies – working alongside the Principal Investigator (PI) and Clinical Research Coordinators (CRCs) to ensure the successful performance of clinical research trials. Team Members in this role are expected to follow Good Clinical Practice (GCP) in the conduct of clinical investigations and to collect, record, and maintain source and sponsor documentation.
RESPONSIBILITIES
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Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with the PI and CRC.
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Assist the team in the performance of clinical research studies, ensuring that procedures completed adhere strictly to the study protocol, including meeting all protocol requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and other requirements.
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Assist the PI and CRC in educating the patients and their family members regarding the clinical trials process and the details of the specific study in which they’re participating.
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Support the PI and CRC in assessing the eligibility of potential patients and help to oversee patient enrollment to ensure that informed consent is properly obtained and documented.
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Coordinate and conduct patient visit procedures (drawing blood, collecting vital signs, performing ECGs, and processing and specimens) as directed.
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Assure that all study visit procedures are conducted in compliance with the clinical trial protocol and Good Clinical Practice (GCP) and according to the site’s Standard Operating Procedures (SOPs).
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Ensure that necessary study supplies are available to conduct required clinical trial visits and procedures according to the trial protocol.
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Communicate clinical trial issues to the PI and CRC and facilitate issue documentation and communication within the organization and with sponsoring and vendor agencies, as needed.
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Keep all source documentation up-to-date and in compliance with ALCOA-C standards.
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Assist the PI and CRC in communicating closely with the sponsor and/or Contract Research Organization’s Clinical Research Associate (CRA) to facilitate the study monitoring and data maintenance processes.
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Complete all monitor and sponsor queries in a timely manner, as directed by the PI and CRC.
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Assist the PI and CRC in tracking the enrollment status of patients and in providing timely communication with patients regarding their study participation.
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As directed by the PI and CRC, prepare for and/or participate in quality assurance audits conducted by study sponsors, federal agencies, or other review groups.
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Perform other duties as assigned by the PI and CRC that ensure the efficient and effective conduct of the clinical trial.
KNOWLEDGE, SKILLS, AND ABILITIES
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Excellent interpersonal and customer service skills.
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Knowledge of medical terminology.
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Exceptional organizational skills and attention to detail.
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Strong verbal and written communication skills.
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Ability to work well both independently and as part of a team.
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Ability to handle multiple tasks simultaneously and adapt to changes in responsibilities and workloads.
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Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters, and other sensitive information.
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Phlebotomy skills are a plus.
QUALIFICATIONS
Education
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Bachelor’s degree preferred – preferably in psychology, biology, health sciences, or a related field.
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Medical Assistant (MA), Certified Phlebotomy Technician (CPT), Licensed Practical Nurse (LPN), or other medical licensure or certification is a plus.
Experience
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1-3 years of related experience required.
PHYSICAL REQUIREMENTS
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Prolonged periods of sitting at a desk and working on a computer.
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Prolonged periods of standing, bending, and reaching.
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Must be physically able to assist patients as needed, and able to lift up to 30 pounds at times.
Charter Research provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability status, genetic information, marital status, ancestry, protected veteran status, or any other characteristic protected by applicable federal, state, and local laws.
