Job Description

Job Description

Job Description

Summa r y: The Clinical Research Coordinator will plan, direct, or coordinate clinical research projects, and will evaluate, analyze clinical data and exercise discretion and independent judgment with matters of significance.

Responsibilities: The Clinical Research Coordinator:

• Performs study subject visits by, among other things;
• Screening and recruiting subjects;
• Dosing and administering study drugs and/or implementing study methodologies;
• Accounting for study drugs;
• Communicating with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators;
• Collecting, labeling, storing, and shipping specimens collected from subjects in connection with a clinical research trial;
• Entering patient and research data in systems designated by the Company; and
• Maintaining patient charts and resolving research queries.
• Follows Good Clinical Practice
• Works cooperatively with others
• Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and Site requirements and policies;
• Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms;
• Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed;
• Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals;
• Oversees subject enrollment to ensure that informed consent is properly obtained and documented;
• Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies;
• Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups;
• Creates source documents as assigned, such as regarding protocols, memos, patient participation;
• Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports;
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks;
• Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures;
• Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions;
• Communicates with laboratories or investigators regarding laboratory findings;
• Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research;
• Orders drugs or devices necessary for study completion;
• Documents findings and events in the Company’s research CTMS platform and in other binders and platforms as directed;
• Occasional travel to Company sites, Investigator meetings, and/or Company meetings; and
• Performs other duties as assigned, including duties routinely performed by the Company’s Research Assistants.

Requirements:

• Knowledge of medical terminology
• Understanding the principles of administration and management

Education:

• High School Diploma
• Or a degree in nursing or health related field
• And 1-5 years of on-the-job training as a clinical research assistant or research study coordinator

Continuing Education:

• IATA (dangerous goods handling)
• GCP (good clinical practice)
• BLS/Phlebotomist course, if required for the position
• CPR course, as arranged from time to time by the Company on-site
• Stericycle Trainings, first week of your start date
• Maintain evidence of completion of all continuing education

Physical Requirements and/or environmental factors:

• Prolonged periods of sitting at a desk and working on a computer
• Prolonged periods of standing and walking around the office
• Must be able to lift 20 pounds at times
• Travel to sponsor required meetings as needed
• Exposure to human bodily fluids
• Occasional night and weekend work schedules
• Overtime may be required at times
• Work is normally performed in a typical interior clinical/office environment

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