SAE Coordinator Assistant

IQVIA•Irving, TX

2d•$29,400 - $73,400

About The Position

Under the direction and supervision of the Research Coordinator Manager, this position is responsible for supporting the SAE Coordinator team with record requests and data entry. The position works closely with the SAE Coordinators and serves as their backup for SAE record gathering and reporting in support of all ongoing clinical studies. Essential and other important responsibilities and duties may include but are not limited to the following: · Demonstrates an understanding of patient/sponsor confidentiality to protect the patient and practice. · Following HIPAA guidelines gathers patient records from a variety of sources (i.e., mail, fax/eFax, email, etc.), which will require interacting with medical records departments, registration areas, and/or physicians' offices in a professional manner. · Keeps practice health care providers informed by communicating availability or unavailability of the record. · Handles serious adverse event medical record requests and related releases of information ensuring that all releases are compliant with HIPAA guidelines. · Provides support and information to onsite and remote monitors as necessary and as directed by supervisor(s). · Serves as a backup to the SAE Coordinators to include: · Submission of serious adverse reports by paper form or case report form (CRF). · Assist with data entry of SAEs into the EMR and/or to the case report form. · Meets with sponsor/monitors to review SAEs as required. · Complies with all applicable regulations, guidelines and procedures pertaining to data loading, EDC and clinical research. · Attends meetings and briefings regarding clinical studies as required. · Ability to maintain a positive attitude with the research team. · Maintain professional demeanor with sponsors and outside medical records facilities. · Remains current with all required training. · Performs other duties as assigned

Requirements

Knowledge of Phase I oncology clinical research preferred.
Excellent interpersonal skills to deal effectively with research personnel.
Knowledge of medical terminology.
Working knowledge of clinical research Electronic Data Capture (EDC) systems.
Knowledge of ICH GCP, FDA, OHRP, OSHA and HIPAA guidelines pertaining to clinical research.
Excellent organizational skills to independently manage workflow.
Ability to prioritize quickly and appropriately with minimal guidance.
Ability to multi-task.
Ability to work independently and function as part of a team.
Clear and concise verbal and written communications.
Minimum of BS preferably in Health Sciences.

Responsibilities

Demonstrates an understanding of patient/sponsor confidentiality to protect the patient and practice.
Following HIPAA guidelines gathers patient records from a variety of sources (i.e., mail, fax/eFax, email, etc.), which will require interacting with medical records departments, registration areas, and/or physicians' offices in a professional manner.
Keeps practice health care providers informed by communicating availability or unavailability of the record.
Handles serious adverse event medical record requests and related releases of information ensuring that all releases are compliant with HIPAA guidelines.
Provides support and information to onsite and remote monitors as necessary and as directed by supervisor(s).
Serves as a backup to the SAE Coordinators to include:
Submission of serious adverse reports by paper form or case report form (CRF).
Assist with data entry of SAEs into the EMR and/or to the case report form.
Meets with sponsor/monitors to review SAEs as required.
Complies with all applicable regulations, guidelines and procedures pertaining to data loading, EDC and clinical research.
Attends meetings and briefings regarding clinical studies as required.
Ability to maintain a positive attitude with the research team.
Maintain professional demeanor with sponsors and outside medical records facilities.
Remains current with all required training.
Performs other duties as assigned