Clinical Research Coordinator (FOCD-Research)

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    "jobTitle": "Clinical Research Coordinator (FOCD-Research)",
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    "description": "<p><span style=\"font-size:14px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\"><span style=\"color:#000000;\">The Clinical Research Coordinator leads and manages clinical trials in compliance with regulatory standards, working closely with the investigative team, pharmaceutical sponsors, and research participants. This role requires a strong medical background, proficiency in Good Clinical Practices (GCP), FDA regulations, and a commitment to ethical research standards.  </span></span></span></p>\n\n<p><br />\n<span style=\"font-size:14px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\"><span style=\"color:#000000;\"><strong>KEY RESPONSIBILITIES: </strong><br />\nDuties will include, but are not limited to:</span></span></span></p>\n\n<p><span style=\"font-size:14px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\"><span style=\"color:#000000;\">•    Manage and oversee the execution of clinical trials under the direction of the Principal Investigator and Site Manager.<br />\n•    Conduct patient visits and ensure adherence to study protocols, collecting and processing biological specimens (blood/urine) and performing procedures such as ECGs and vital signs monitoring.<br />\n•    Administer questionnaires, diaries, and other participant materials as per protocol.<br />\n•    Schedule and coordinate research visits, assessments, and procedures, ensuring all requirements are met.<br />\n•    Maintain accurate case report forms, cross-referencing patient medical records for completeness and FDA compliance.<br />\n•    Collect, enter, and manage clinical data while maintaining confidentiality.<br />\n•    Monitor study participants, ensuring adherence to study guidelines and ethical standards.<br />\n•    Manage investigational medications, including receiving, dispensing, and performing drug accountability.<br />\n•    Collaborate with laboratories to process, ship, and ensure review of investigational reports.<br />\n•    Actively participate in recruiting and screening study participants.<br />\n•    Maintain organized records of study materials, ensuring all regulatory documentation is up to date.<br />\n•    Ensure necessary supplies and equipment are available and functional for each study.<br />\n•    Complying with company policies, HIPAA, OSHA regulations, and Standard Operating Procedures (SOPs) to deliver high-quality services.</span></span></span></p>\n\n<p> </p>\n\n<p><span style=\"font-size:14px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\"><span style=\"color:#000000;\"><strong>SKILLS &amp; EXPERIENCE:</strong></span></span></span></p>\n\n<p><br />\n<span style=\"font-size:14px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\"><span style=\"color:#000000;\">•    Strong knowledge of medical terminology, clinical trial processes, and industry regulations.<br />\n•    Excellent problem-solving, leadership, and communication skills.<br />\n•    Ability to work both independently and collaboratively as part of a team.<br />\n•    Proficient with computer hardware and software, including clinical research databases.<br />\n•    Strong attention to detail and organizational skills.<br />\n•    Ability to maintain confidentiality and handle sensitive information.<br />\n•    Outstanding interpersonal skills, with the ability to establish and maintain effective relationships with patients, investigators, and external partners.<br />\n•    Willingness to learn and stay updated on new clinical research trends and regulations.<br />\n•    Phlebotomy experience and certification where required.<br />\n•    CCRC certification a plus .<br />\n•    Bi-lingual in Spanish is a plus.</span></span></span></p>\n\n<p><br />\n<span style=\"font-size:14px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\"><span style=\"color:#000000;\"><strong>ESSENTIAL FUNCTIONS:</strong></span></span></span></p>\n\n<p><br />\n<span style=\"font-size:14px;\"><span style=\"font-family:Arial, Helvetica, sans-serif;\"><span style=\"color:#000000;\">•    Ability to prioritize tasks, manage deadlines, and adapt to changing environments.<br />\n•    Ability to receive and process information through both oral and written communication.<br />\n•    Proficient in accessing, inputting, and retrieving data from a computer.<br />\n•    Ability to sit or stand for 6-8 hours a day and lift or carry 5-10 pounds occasionally.<br />\n•    Requires substantial use of wrists, hands, and fingers for tasks such as typing and filing.</span></span></span><br />\n </p>",
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