POSITION SUMMARY
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 serious adverse event (SAE) record gathering and reporting in support of all ongoing clinical studies.
PHYSICAL DEMANDS
PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS
- 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 SAE 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:
o Submission of serious adverse reports by paper form or case report form (CRF).
o Assist with data entry of SAEs into the EMR.
o Complies with all applicable regulations, guidelines and procedures pertaining to data loading, EDC and clinical research.
- Meets with sponsor/monitors to review data entry as required.
- 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 AND SKILLS
- Minimum of BS preferably in Health Sciences.
- Preferably knowledge of Phase I oncology clinical research.
- 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.
PHYSICAL DEMANDS
- 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.
- o Requires sitting and talking on the telephone for extended periods of time.
- o Requires corrected vision and hearing to normal range.
- o Requires outgoing and friendly personality for interaction with internal and external parties.
JOB TYPE
- Full-time
- Non-Exempt
- Remote position
- Monday to Friday
- 8am to 5pm
- There will be times when an adjustment in work hours to include weekends is necessary.
$22.00 – $27.00/hr
