Job Description
JOB SUMMARY
Under minimal supervision, is responsible for the collection, coordination, processing, and quality control of clinical trial data. May assist with screening patients for research protocols. Maintains research protocol information, regulatory documents, and other research files as applicable. Works in compliance with USA Clinical Trials (USACT) Standard Operating Procedure (SOP), principles of Good Clinical Practice, and all applicable federal, state, and local regulations
. Responsibilities:
- Extrapolates data completes case report forms, and ensures timely data submission in accordance with USACT SOP.
- Actively prepares for and participates in monitoring and auditing activities. Assists in ensuring that all queries are resolved in a timely manner in accordance with USACT SOP and sponsor requirements.
- May assist with screening patients for potential study enrollment.
- Responsible for assisting with patient scheduling for procedures required to maintain protocol compliance.
- Responsible for assisting with coordinating patient follow-up visits and timely data submission.
- Responsible for assisting with the collection and processing of specimens, imaging documents, or other items required for research purposes.
- Responsible for ordering and maintaining research supplies.
- Responsible for assisting in the investigational drug accountability process.
- Maintains research records in a confidential manner according to practice policies, sponsor confidentiality agreements, HIPAA guidelines, and any other applicable regulations.
- May lead and mentor other data coordinators at the site/location
- Responsible for documenting patient stipend reconciliation.
- Responsible for assisting with startup activities (attending pre-study site qualification visits, Study initiation visits, IRB Submissions, obtaining training log signatures, and delegating personnel)
- Responsible for assisting with patient scheduling for procedures required to maintain protocol compliance
- Obtains vital signs, bladder volumes, and questionnaires from study subjects on stress incontinence trials
- Collects adverse events, diaries, medications, and medical history from patients and records on source
- Reviews and obtains informed consent from potential subjects
- Assists with the creation of source for CRC using eCRF/protocol guidelines for each trial
- Conducts thorough and precise reviews of all study charts and indicates data points that are missing or discrepant to clinical research coordinators
- Receives study drug shipments and verifies that the drug received matches the shipping receipt
- Assists with verification of study drug against dispense log prior to dispensing to patient
- Responsible for assisting with closeout activities (EDC cleanup, subject/regulatory binder source cleanup, archiving subject/regulatory binders)
- Incorporates the AIDET methodology with patient care and staff collaborations.
- Punctual and regular attendance is an essential responsibility of each employee. Employees are expected to report to work as scheduled, on time, and prepared to start working. Employees also are expected to remain at work for their entire work schedule. Late arrival, early departure, or other absences from scheduled hours are disruptive.
- Completes all Corporate training on time.
DUTIES AND ESSENTIAL JOB FUNCTIONS
- Follow protocol-specific requirements to successfully carry out the study
- Code, evaluate, or interpret collected study data.
- Document and maintain required records necessary for study activities per local, state, and FDA GCP requirements.
- Maintain professional communication with investigators, sponsors, and study personnel.
- Willing to travel to various Urology San Antonio offices
- Must be flexible and adaptable to a changing environment with our growing research department
- Assist with identifying eligible patients for studies requiring case and healthy control subjects
Other functions and Responsibilities
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
COMPETENCIES
- Patient & Customer Focus
- Ethical Conduct
- Flexibility
- Initiative
- Personal Effectiveness/Credibility
- Stress Management/Composure
QUALIFICATIONS
Required
- High attention to detail and strong organizational skills
- Excellent written and verbal communication skills
- Ability to work well independently
- Maintain confidentiality
- Experience with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)
- Clinical research certification is a plus but not required
- Experience managing operations (coordinating/scheduling patient visits)
- Possess strong skills for multitasking, meeting competing deadlines, prioritizing, and supporting PIs for multiple projects
- Research: 3-5 years
QUALIFICATIONS
Required
- 1 or more years of recent Research related experience (with human participants preferred)
- Prior experience in a similar-sized facility and comparable services provided.
- Experience and knowledge of the purpose and use of medications in the treatment of cancer.
REQUIRED LICENSES/CERTIFICATIONS
Required
- Bachelor's degree in a science-related field (e.g. biology, genetics, life sciences, etc.) and experience working with human subjects
Job Tags
Local area, Flexible hours,