SAE Coordinator

Job Summary

Under the direction and supervision of the Assistant Director of Clinical Trial Management this position is responsible for all serious adverse event (SAE) reporting SAE record requests and SAE data entry. The position works closely with the NEXT Investigators at all NEXT sites in support of all ongoing clinical studies.

Essential Duties and Responsibilities

• Essential and other important responsibilities and duties may include but are not limited to the following:

• Provides timely accurate and complete submission of SAEs (initial and follow-ups) to the sponsor/or designee by paper form or case report form (CRF).

• Responsible for data entry of SAEs into the electronic medical record (EMR) system.

• Serves as a backup to the SAE Coordinator Assistant to include:

• SAE medical record requests and related releases of information ensuring that all releases are compliant with HIPAA guidelines.

• Keeps practice health care providers informed by communicating availability or unavailability of the record(s).

• Following HIPAA guidelines when requesting 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.

• Demonstrates an understanding of patient/sponsor confidentiality to protect the patient and practice when providing patient records.

• Meets with sponsor/monitors to review SAEs as required and as directed by supervisor(s).

• 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.

• Perform other duties as assigned

Knowledge Skills & Abilities

• Knowledge of Phase I oncology clinical research.

• Knowledge of appropriate software including Microsoft suite applications and Adobe Acrobat Pro.

• 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.

Required Education and Experience

• Minimum of BS preferably in Health Sciences

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role when annualized is $43400.00 - $108200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge skills education and experience; location; and/or schedule (full or part-time). Dependent on the position offered incentive plans bonuses and/or other forms of compensation may be offered in addition to a range of health and welfare and/or other benefits.