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.

Remains current with all required training.

Performs other duties as assigned.

Knowledge, Skills and 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.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requires full range of body motion including handling and lifting, manual and finger dexterity, and eye-hand coordination.

Requires sitting and standing for extensive periods of time.

Occasionally lifts and carries items weighing up to 40 lbs.

Must have vision and hearing that are effectively functional with or without corrective measures.