Clinical Research Assistant / Medical Assistant

Come work with a growing, multi-site clinical research team!

Clinical Research Assistant Job Description:

PURPOSE

Under the direction of the Research Manager, this position assists with the execution of new studies and maintenance of open and closed studies, as applicable. This position assists with clinical and administrative activities for clinical studies. This position works in close coordination with all team Clinical Research Coordinators, Follow-Up Clinical Research Coordinators, Clinical Research Assistants, Investigators, study monitors/Clinical Research Associates (CRAs), sponsors, Clinical Research Organizations (CROs) and the ECIR Compliance Manager to carry out the trial.
To work as an integral member of ECIR research staff maintaining the day-to-day relationship with ECIR sites and assist in the development of the ECIR network. This includes planning, coordinating and, as appropriate, execution of clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor, CRO, and ECIR SOP’s and any relevant local guidelines and regulations.

RESPONSIBILITIES

• Assists the Principal Investigator (PI) and other research staff to help ensure that clinical research and related activities are performed in accordance with federal regulations and ECIR’s Standard Operating Procedures (SOPs).
• Assists with maintaining the documentation of appropriate and necessary training of research staff trained on study specific training log.
• Cooperates with ECIR compliance and monitoring efforts and reports instances of noncompliance to the ECIR Director of Clinical Operations and ECIR Compliance Manager.
• Assists with monitoring and auditing visits. Notifies ECIR Director of Clinical Operations and ECIR Compliance Manager of external audits by FDA, sponsors, and Clinical Research Organizations (CROs).
• Attend and participate in investigator meetings, monitoring visits, audits, seminars, and other regional or national meetings as required or requested.
• Assists the ECIR Compliance Manager and Clinical Research Coordinator in the collecting of study documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, Financial Disclosure Forms, CVs, etc.)
• Organizes and maintains filing in all study files, including but not limited to, regulatory binders, study specific source documentation, and other materials.
• Attends Site Initiation Visits (SIVs), Interim Monitor Visits (IMVs), and Close Out Visits (COVs) as requested.
• Reviews and develops a familiarity with the protocol, e.g., study procedures and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Creates study specific source documentation templates utilizing the study protocol, study Case Report Form (CRF) or electronic CRF screenshots, ECIR SOPs, and other provided resources prior to the SIV.

• Prepares study subject research binders by gathering, creating, and including necessary forms, logs, and study source document templates to prepare for subject enrollment.
• Registers subjects to the appropriate coordinating center (if multi-site study), such as through the Interactive Web Response System (IWRS).
• Assists with the coordination of subject’s physical exams with appropriate study investigators and other tests and procedures required by the study protocol.
• Assists with the collection of study data as required by the protocol. Assures timely completion of Case Report Forms.
• Completes study documentation and maintains study files in accordance with sponsor requirements and ECIR SOPs including, but not limited to, consent forms, source documentation, case report forms, and investigational product accountability forms.
• Performs specimen processing and shipment of biological specimen duties.
• Assists Clinical Research Coordinators with the functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the PI, in accordance with local country requirements and licensures.
• Assists Clinical Research Coordinators with the accurate completion of source documents and case report forms in both paper and electronic format.
• Performs timely submission of study visit data into the Electronic Data Capture (EDC) system, if applicable.
• Assists investigators and Clinical Research Coordinators with recording and reporting of adverse events (AEs) and Serous AEs (SAEs) within appropriate timeframes as per the study protocol, IRB, and local regulatory authority guidelines.
• Schedules study participant appointments and serves as the patient liaison to the PI and other participating investigators.
• Performs study visit reminder phone calls to study subjects for upcoming research appointments.
• Requests Medical Records, certify prints Medical Records from clinic Electronic Medical Records (if applicable), and extracts data from patient records in a timely manner.
• Distributes Dear Doctor Letters, informing research subject’s primary care physicians of their participation in the research study, as requested by the study subject.
• Responds to data clarification requests and queries in a timely manner, according to the study protocol and ECIR SOPs.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or ECIR SOPs on Investigational Product Accountability.

• Maintains effective and ongoing communication with sponsor, CRO, research subjects, and PI during the course of the study.
• Works with the PI and Clinical Research Coordinator to manage the day to day activities of the study including problem solving, communication and protocol management.
• Registers each subject visit in the ECIR Clinical Trial Management System (CTMS), Clinical Conductor in a timely manner to ensure billing of study procedures to the appropriate funding source.
• May perform other job-related duties as requested or required.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Medical Assistant certification or similar highly preferred
• Sound knowledge of medical terminology.
• Sound knowledge of ICH/GCP and Regulatory requirements.
• Knowledge of good clinical practice (GCP), FDA and HIPAA policies and practices.
• Knowledge of International Air Transport Association (IATA) Dangerous Goods Regulations.
• Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
• Proficient in the use of Microsoft Office and Excel.
• Fluent in spoken and written English language.
• Strong organizational skills and meticulous attention to detail.
• Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
• Ability to maintain confidentiality.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.