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 FMC Science Standard Operating Procedures (SOP) principles of Good Clinical Practice and all applicable federal, state, and local regulations. Supports and adheres to the FMC Science to include the Code of Ethics and Business Standards.
Essential Duties and Responsibilities:
Extrapolates data, completes case report forms, and ensures timely data submission in accordance with FMCS SOP.
Utilizes FMC Science’s CTMS system to track trial participant visits and ensure that data entry is completed with each patient visit
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 FMCS SOP and sponsor requirements.
May assist with processing, filing, and maintaining protocol regulatory documents.
Responsible for processing, packaging and shipping laboratory samples in accordance with IATA guidelines.
May assist with collection of vital signs and EKGs and other various assessments (as appropriately trained) of study participants.
Responsible for assisting with chart review and recruitment, and may assist in 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 collection and processing of specimens, imaging documents, or other items required for research purposes.
May be 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.
High school diploma or equivalent required, some college coursework or other relevant background preferred. Three-five years medical office experience and knowledge of medical terminology required. Prior experience as data coordinator required. SoCRA or ACRP certifications preferred. Must be proficient in Microsoft Office applications. Experience in electronic data capture systems preferred.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Required hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and vision correctable to 20/20. Requires occasional lifting of up to 30 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function. While performing the duties of this job, the employee us exposed to conditions typical in a medical office setting
About FMCSCIENCE, LLC
FMC Science is an independently owned and operated research site with locations in Lampasas and Georgetown. We strive to provide expert care and quality work in a caring environment. Our number one priority is the safety of our research participants.