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
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.
- Responsibilities:
- Assist the Research Coordinate in the coordination of studies according to ICH and GCP guidelines as specified in the protocol.
- Assists in the daily clinical trial activities and plays a critical role in the conduct of the study.
- Assists in the Scheduling of study participant appointments and serves as the patient liaison to the PI and other participating physicians.
- Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
- Working closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process.
- Coordinates and facilitates monitoring and auditing visits. Notifies appropriate ICR officials of external audits by IRB’s, Regulatory agencies, CRO’s and sponsors.
- Collaborates with PI and ICR to respond to any audit findings and implement-approved recommendations.
- Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits.
- Completes case report forms. Extracts data from patient charts in a timely manner
- Responds to data clarification requests in a timely manner.
- Coordinates with PIs to help ensure that clinical research and related activities are performed in accordance with Federal regulations, ICR and sponsoring agency policies and procedures.
- Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains records and other documentation of training.
- Maintains subject screening logs and protocol deviation logs.
- Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis.
- Ensures that all materials for each clinical trial protocol are available for subject enrollment.
- Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data.
- Performs specimen processing and shipment of biological specimen duties.
- Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Establishes and organizes study files, including but not limited to, study specific source documentation and other materials as required.
- Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures.
- Arranges secure storage of study documents that will be maintained according to USACT institutional policy or for the contracted length of time, whichever is longer.
- Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research to the Director of Research.
- May perform other job-related duties as requested or required
- REQUIRED SKILLS
- Ability to work with other research team members and have strong organizational and time management skills
- Strong critical thinking and problem-solving skills
- Ability to work under pressure
- Dependable
- Exercises safe judgment in decision making
- Demonstrates tact and understanding when dealing with patients, team members, members of other disciplines, and the public
- Must possess honesty, integrity, and accountability
- Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors and sponsors.
- Knowledge of medical terminology.
- Knowledge of good clinical practice, FDA, OHRP, HIPAA policies.
- Previous work with CRFs and EDC.
- Excellent organizational skills to independently manage work flow.
- Ability to prioritize quickly and appropriately.
- Ability to multi-task.
- Meticulous attention to detail
- 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
COMPETENCIES
- Patient & Customer Focus
- Ethical Conduct
- Flexibility
- Initiative
- Personal Effectiveness/Credibility
- 6. 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 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
- Current BLS
- 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
REQUIRED LICENSES/CERTIFICATIONS
- Bachelor's degree in a science related field (e.g. biology, genetics, life sciences, etc.) and experience working with human subjects
