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.