Clinical Research Coordinator II

Integrated Resources, Inc

Brownsville, TX

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JOB DETAILS

JOB TYPE

Contractor

SKILLS

Case Report Form (CRF), Clinical Assessment, Clinical Research, Clinical Support, Clinical Trial, Communication Skills, Cross-Functional, Data Collection, Data Entry, Detail Oriented, Electrocardiogram, Electronic Data Capture (EDC), English Language, Establish Priorities, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Healthcare, ICH Regulations, IP (Internet Protocol), IRB/IEC (Institutional Review Board/Independent Ethics Committee), Information Technology & Information Systems, Informed Consent, Licensed Practical Nurse/Licensed Vocational Nurse, Medical Records, Medical Tests, Nursing Credentials, Operations Processes, Organizational Skills, Patient Care, Patient Follow-up, Patient Safety, Problem Solving Skills, Research Protocols, Site Initiation, Standard Operating Procedures (SOP)

LOCATION

Brownsville, TX

POSTED

30+ days ago

Job Title: Clinical Research Coordinator II Job Location: Brownsville, TX 78521 Job Duration: 6+ Months (possibility of extension) Shift Time: Days, Monday-Friday Summarized Purpose: Study coordinator to support ongoing large clinical study in US. Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process. Interacts with the research site team and other interdepartmental staff. Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry, and query resolution. Essential Functions: Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines. Provides medical care to patients, always ensuring patient safety comes first. Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized. Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.). Records all patient information and results from tests as per protocol on required forms. Where required, may complete IP accountability logs and associated information. Reports suspected non-compliance to relevant site staff. Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study. Promotes the company and builds a positive relationship with patients to ensure retention. Attends site initiation meetings and all other relevant meetings to receive training on protocol. May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results. Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe. Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up-to-date information is recorded. Adheres to company COP/SCOP. May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility. Education and Experience: Bachelor's degree or equivalent and relevant formal academic/vocational qualification in the clinical/medical field. Must hold a valid nursing license (RN, LVN, LPN) within the country operating. Must be registered with local health care authority. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’). Knowledge, Skills and Abilities: Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.). Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving. Demonstrated ability to exercise discretion and sound judgement. Good decision-making, negotiation, and influencing skills. Good communication skills and English fluency will be an advantage. Good organizational skills. Good proficiency in basic computer applications. Good interpersonal skills to work in a team environment.

About the Company

Integrated Resources, Inc

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