Clinical Research Project Manager (Biggs Institute) en O9800 - HOPD Mays Cancer Center
O9800 - HOPD Mays Cancer Center · San Antonio, Estados Unidos De América · Onsite
- Professional
- Oficina en San Antonio
An open, fully funded position for a Clinical Research Project Manager is available in the Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases at the University of Texas Health San Antonio (UTHSA) (https://biggsinstitute.org/). We are looking for an exceptional candidate with expertise in clinical trials research to join a collaborative team of clinicians, epidemiologists, and statisticians conducting state-of-the art research on dementia.
The position provides opportunities to work with Investigators conducting research on dementia as part of the NIA-funded South Texas Alzheimer’s Disease Research Center. The candidate will work closely with the Investigators of various Industry sponsored clinical trials to coordinate and participate in a variety of complex activities including study start-up, recruitment, (pre) Screening, administering cognitive assessments, research study documentation, data entry, maintenance of appropriate research regulatory documentation and quality control review.
The candidate will perform diverse research and administrative duties requiring sound judgment. The candidate must be self-motivated, independent in task completion, and comfortable accepting feedback and guidance from colleagues. The ability to work well in a team and excellent communication skills are a must.
Responsibilities
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Oversees and coordinates all aspects of a clinical trial, including the planning, evaluation, implementation, and documentation of clinical trial progress.
- Supports management of the trial by working with key internal and external project members, clinical research associates (CRAs), auditors, study sponsors, and the principal investigator of the study.
- Executes study management activities including timeline, risk management, budget monitor, and patient safety.
- Ensures the studies adhere to regulations and timelines provided by the study sponsor.
- Occasional participates in active recruitment, screening, and enrollment of potential study candidates, including discussing study protocols with potential study candidates and obtaining informed consent.
- Anticipates, manages, and escalates issues as appropriate
- Develops and maintains study source documents and Case Report Forms, prepares study timelines, and when necessary, reports adverse events to the PI and obtains necessary documentation of causality Findings .
- Ensures compliance with all federal and local regulations and that all regulatory processes are correct and align with the policies of UTHSCSA as well as various research organizations.
- Monitors close-out of studies and ensures records are retained for appropriate length of time.
- Reviews goals and requirements of any new protocols; plans and designs source documentation for protocol; and coordinates study initiation.
- Maintains excellent communication with the investigative team.
- Provides staff training and oversight of research.
- Proficient in using Microsoft Office (Word, Excel, PowerPoint) and data capture systems such as RedCap.
- Provides routine technical/administrative assistance in performing assigned and delegated tasks in support of research projects to ensure continuous clinical research operations.
- Assists with the development of new protocols, project reports, IRB submissions, and grant submissions.
- Performs all other duties as assigned.
Qualifications
- High attention to detail and strong organizational skills.
- Excellent written and verbal communication skills.
- Ability to work well independently with research participants and staff with minimal supervision.
- Possess strong skills for multitasking, meeting competing deadlines, prioritizing and supporting the investigator team.
- Strong ethics and professionalism.
EDUCATION:
- Bachelor's degree in a related field is required.
EXPERIENCE:
- Minimum of three (3) years of progressive experience in protocol implementation, research coordination, data collection, and/or facilitating the patient experience in research projects.
- Working knowledge of industry-sponsored clinical trials and project management methodologies preferred.
- Clinical Research Coordinator (CRC) certification strongly preferred.
- Bilingual proficiency in English and Spanish preferred.
