SAE Coordinator Assistant

IQVIA•Irving, TX

4d•$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 Duties and Responsibilities 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 Knowledge, Skills and Abilities · 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. 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 https://jobs.iqvia.com 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. https://jobs.iqvia.com/eoe IQVIA 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 $29,400.00 - $73,400.00. 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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

Requirements

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.

Nice To Haves

Knowledge of Phase I oncology clinical research preferred.

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