Posted: Friday, March 9, 2018 12:37 AM
Name of Location: Egleston
Work Schedule: Day
Employment Type: Full:Time
Monday : Friday
JOB SUMMARY 13;
Supports the efforts of investigators initiating clinical research studies by developing and submitting various regulatory and technical documents required in Food and Drug Administration (FDA) submissions, Institutional Review Board submissions and other required documents for the initiation of these projects. Drafts, reviews, edits and finalizes documents by organizing, analyzing, and interpreting scientific and statistical data.
:Bachelors degree in a scientific or health:related field 13;
CERTIFICATION SUMMARY 13;
:Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of employment
:Collaborative Institutional Training Initiative (CITI) within 30 days of employment 13;
:5 years of experience in clinical research in a medical/behavioral setting with knowledge about the conduct of clinical trials, research principles, and methodologies/study design
:1 year of experience in supervising staff
:2 years of experience developing, submitting and executing clinical research projects 13;
PREFERRED QUALIFICATIONS* 13;
:Masters degree in scientific or health related field 13;
KNOWLEDGE SKILLS and ABILITIES* 13;
:Strong writing skills with strong attention to detail
:Demonstrated ability to manage timelines
:Self:directed and motivated to work independently toward short: and long:term goals
:Thorough understanding of documentation requirements related to IND and IDE submissions 13;
JOB RESPONSIBILITIES* 13;
:Prepares Investigative New Drug (IND) submission packets for the FDA that present clinical data objectively and in a clear concise format.
:Develops clinical research protocols for investigator:initiated studies.
:Develops eIND, Humanitarian Use device (HUDs) etc. for compassionate use needs
:Develops informed consent documents for investigator initiated protocols
:Oversees INDs, eINDs, HUDs etc to ensure compliance and timely reporting
:Collaborates with physicians to ensure accurate and timely submissions.
:Provides coordination of research studies as needed.
:Stays abreast of current industry practices and regulatory requirements and guidelines that affect medical writing. 13;
SYSTEM RESPONSIBILITIES* 13;
Safety: Practices proper safety techniques in accordance with hospital and departmental policies and procedures. Responsible for the reporting of employee/patient/visitor injuries or accidents, or other safety issues to the supervisor and in the occurrence notification system.
Compliance: Monitors and ensures compliance with all regulatory requirements, organizational standards, and policies and procedures related to area of responsibility. Identifies potential risk areas within area of responsibility and supports problem resolution process. Maintains records of compliance activities and reports compliance activities to the Compliance Office.
The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be an exhaustive list of all job duties performed by the personnel so classified.
PHYSICAL DEMANDS* 13;
Ability to lift up to 15 lbs independently not to exceed 50 lbs without assistance 13;
Hearing/Speaking : Effective communication with employees, supervisors/managers and staff. Effective communications with patients and visitors, as required. 13;
Bending/Stooping : Occasionally (activity or condition exists up to 1/3 of time) 13;
Climbing : Occasionally (activity or condition exists up to 1/3 of time) 13;
• Location: Atlanta
• Post ID: 93999327 atlanta