POSITION SUMMARY
The Research Assistant is responsible for helping the Study Coordinator in the coordination and implementation of clinical protocols from pre-study planning through the successful completion of patient visits and documentation.
ESSENTIAL FUNCTIONS
Practices with ethical and legal guidelines
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.
May attend Investigator meetings requiring travel and report pertinent information back to research team members.
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, regulatory binders, 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 SCRG 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
WORK ENVIRONMENT
The Research Study Coordinator will work primarily in an office setting; some travel required to satellite locations and outside meetings (see TRAVEL).
PHYSICAL DEMANDS
Must be able to move intermittently throughout the workday
Must be able to speak and write the English language in an understandable manner
Requires repetitive hand motion
Minimal lifting and carrying requirements
TRAVEL
Minimal travel to satellite locations and outside meetings
DIRECT REPORTS
None
REQUIRED EDUCATION/EXPERIENCE
High school diploma or GED
PREFERRED EDUCATION/EXPERIENCE
Associate Degree in Science.
CERTIFICATIONS
COA preferred
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Schedule:
Experience:
- relevant: 1 year (Preferred)
Work Location: In person