| Information | |
| Job Title | Clinical Research Coordinator - Pharmaceutical CRO - San Antonio  |
| Date | 2009-11-11 |
| Company | Cybercoders.com (View All Jobs) |
| Location | San Antonio, TX 78201 |
| Category | Healthcare |
| Posted by | JobirnPartner |
| Job Description |
Clinical Research Coordinator - Pharmaceutical CRO - San Antonio Clinical Research Coordinator - Pharmaceutical CRO - San Antonio, TX Skills Required Pharmaceutical, Clinical Research Coordinator, Good Clinical Practices (GCP's), Phase I Clinical Studies, IRB Institutional Review Board Clinical Research Coordinator - Pharmaceutical CRO - San Antonio, TX We offer a full range of clinical research services. We provide expert advice on everything from protocol development to regulatory submission. Our modern clinical research facility in San Antonio, TX (250 beds) offer a full range of clinical research services. Responsibilities: * Assure that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines. * Be the primary contact for the study subjects, as well as Sponsors and available for daily communication with study subjects and Sponsor representatives and for communicating problems, questions and/or clarifications to the Sponsor's representatives, as well as to the subjects. * Review study protocol and investigator's brochure for studies they will be assigned to. * Attend the investigator's meeting, pre-study site visit, study initiation visit, and all other study-related visits by monitors or sponsor representatives. * Establish study document binder to maintain complete and accurate records of all sponsor, site, CRO, IRB/IEC correspondence and regulatory documents pertaining to the study. * Prepare source documents specific to the study. This includes study folders and subject information folders, as required by the study. * Review approved regulatory documents from the IRB/IEC, checking for completeness. * Set up a recruitment plan with Recruitment Services Supervisor. Oversees recruitment and works with appropriate personnel to make adjustments as needed. * Meet with Recruitment Services Supervisor and Recruitment Specialists to instruct on protocol specific phone screening questionnaire and scheduling of potential volunteers. * Review subject screening forms prior to subject's appointment to verify screening eligibility. * Comply with in-house documentation requirements. * Meet with Technical Services Supervisor to review study-related procedures, staffing and visit flow. Schedules medical coverage for physicals, etc. with appropriate medical personnel. * Manage the trial from phone screening to randomization to study completion. This includes: 1. Obtaining written informed consent from the subject. 2. Performing subject's pre-screening, screening, and study visits in conjunction with the Physician/Investigator. * Maintain communication and documentation of such communication with Sponsor or Sponsor representative(s) throughout the clinical trial. * Serve as the primary contact for subjects by being available to handle study-specific questions, concerns or events. * Assure quality and completeness of source documents and case report forms collected during the course of the study. Data is entered into case report forms using 100% source documentation verification. * Coordinate monitor visits with Investigator and room availability. Is readily available during monitoring visits for correction, questions, etc. * Distribute to Manager of Clinical Data Management necessary information needed to complete final IRB report at study close-out. * After close-out visit has been conducted, prepares study documents for archiving process within a reasonable amount of time. Requirements: * Bachelor's degree * 2+ years of clinical research experience * In-depth knowledge of the clinical research process, including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting. * Excellent written and oral communication skills. * Basic computer knowledge and applications required for generation of business correspondence and preparation of regulatory and other study documents. * Strong interpersonal skills. * Excellent attention to detail. * Exceptional organizational skills. |
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