Clinical Research Coordinator (Research SBC Pasadena)

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    "description": "<p>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.  </p>\n<p><u><strong>KEY RESPONSIBILITIES: </strong></u></p>\n<p>Duties will include, but are not limited to:</p>\n<ul>\n\t<li>Manage and oversee the execution of clinical trials under the direction of the Principal Investigator and Site Manager.</li>\n\t<li>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.</li>\n\t<li>Administer questionnaires, diaries, and other participant materials as per protocol.</li>\n\t<li>Schedule and coordinate research visits, assessments, and procedures, ensuring all requirements are met.</li>\n\t<li>Maintain accurate case report forms, cross-referencing patient medical records for completeness and FDA compliance.</li>\n\t<li>Collect, enter, and manage clinical data while maintaining confidentiality.</li>\n\t<li>Monitor study participants, ensuring adherence to study guidelines and ethical standards.</li>\n\t<li>Manage investigational medications, including receiving, dispensing, and performing drug accountability. </li>\n\t<li>Collaborate with laboratories to process, ship, and ensure review of investigational reports.</li>\n\t<li>Actively participate in recruiting and screening study participants.</li>\n\t<li>Maintain organized records of study materials, ensuring all regulatory documentation is up to date.</li>\n\t<li>Ensure necessary supplies and equipment are available and functional for each study.</li>\n\t<li>Complying with company policies, HIPAA, OSHA regulations, and Standard Operating Procedures (SOPs) to deliver high-quality services.</li>\n</ul>\n\n<p> </p>\n\n<p><u><strong>SKILLS &amp; EXPERIENCE:</strong></u></p>\n\n<ul>\n\t<li>Strong knowledge of medical terminology, clinical trial processes, and industry regulations.</li>\n\t<li>Excellent problem-solving, leadership, and communication skills.</li>\n\t<li>Ability to work both independently and collaboratively as part of a team.</li>\n\t<li>Proficient with computer hardware and software, including clinical research databases.</li>\n\t<li>Strong attention to detail and organizational skills.</li>\n\t<li>Ability to maintain confidentiality and handle sensitive information.</li>\n\t<li>Outstanding interpersonal skills, with the ability to establish and maintain effective relationships with patients, investigators, and external partners.</li>\n\t<li>Willingness to learn and stay updated on new clinical research trends and regulations.</li>\n</ul>\n\n<p> </p>\n\n<p> </p>\n\n<p><u><strong>ESSENTIAL FUNCTIONS:</strong></u></p>\n\n<ul>\n\t<li>Ability to prioritize tasks, manage deadlines, and adapt to changing environments.</li>\n\t<li>Ability to receive and process information through both oral and written communication.</li>\n\t<li>Proficient in accessing, inputting, and retrieving data from a computer.</li>\n\t<li>Ability to sit or stand for 6-8 hours a day and lift or carry 5-10 pounds occasionally.</li>\n\t<li>Requires substantial use of wrists, hands, and fingers for tasks such as typing and filing.<br />\n\t </li>\n</ul>",
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