Research Data Specialist

• Collect, review, and enter clinical trial data from source documents into appropriate systems and case report forms (CRFs) in a timely and accurate manner.

• Maintain and update research records, including patient tracking logs, protocol documents, and study files.

• Track patient visits and ensure required data and documentation are complete for each study milestone.

• Resolve data discrepancies and respond to data queries by coordinating with research staff as needed.

• Assist with preparation and support of monitoring visits, audits, and sponsor reviews.

• Maintain confidentiality of all patient and research data in accordance with HIPAA, sponsor requirements, and applicable regulations.

• Assist with research-related administrative tasks, including:

• Scheduling study-related appointments or follow-ups

• Ordering and maintaining research supplies, clinical trial drugs, and lab kits

• Filing, organizing, and retrieving study documents

• Assist with collection and processing of study-related materials (e.g., labs, specimens, imaging documentation) as directed.

• Ensure timely submission of required data to sponsors and internal systems including the company EMR.

• Support long-term follow-up tracking for assigned research patients.

• Communicate clearly with clinical and research staff regarding data status, needs, or concerns.

• Perform other duties as assigned to support research operations.

• In a timely manner according to company and HIPAA guidelines, answers requests for information and documents as authorized and documents all information releases.

• Maintains medical record operations by following all company and department policies and procedures.

• Remains current on all compliance requirements and in part, demonstrates a strong knowledge of Adheres to confidentiality, state, federal, and HIPPA (Health Insurance Portability and Accountability Act) laws and guidelines with regards to patient's records and information.

• Attends required, applicable meetings.

• Remains current on all compliance requirements.

• Ensures all applicable policies and procedures of the company and Network are followed.

• Other duties as requested or assigned.

Supervisory Responsibilities:

• None.

Basic Work Requirements:

• Ability to read, understand and follow oral and written instructions.

• Ability to perform clerical tasks at a high level.

• Ability to time manage according to appointment lists and trial requirements.

• Ability to deal courteously directly with providers, patients, co-workers, and outside agencies or company partners.

• Ability to operate a telephone system and utilize appropriate telephone etiquette.

• General knowledge of computer programs such as Microsoft, Adobe and EMR systems.

• General knowledge of standard office equipment such as computers, multifunction machines and desk phones.

• General knowledge of medical terminology.

• Ability to speak clearly and concisely. Ability to hear sounds concisely.

Education/Training/Experience:

• High School Diploma or equivalent required.

• Associates Degree strongly desired.

• Medical office experience is a plus.

• Knowledge of electronic health record systems is a plus.

• Time Management, Organization, Attention to Detail and Quality Focus skills needed.

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. Work may require sitting for long periods of time; also stooping, bending and stretching for files and supplies. Occasionally lifting files or paper weighing up to 30 pounds. Requires manual dexterity sufficient to operate a keyboard, calculator, telephone, copier and other office equipment. Vision must be correctable to 20/20 and hearing must be in the normal range for telephone contacts. It is necessary to view and type on computer screens for prolonged periods of time.

Competencies:

• Uses Technical and Functional Experience: Possesses up to date knowledge of the profession and industry; is regarded as an expert in the technical/functional area; accesses and uses other expert resources when appropriate.

• Demonstrates Adaptability: Handles day to day work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; shows resilience in the face of constraints, frustrations, or adversity; demonstrates flexibility.

• Uses Sound Judgment: Makes timely, cost effective and sound decisions; makes decisions under conditions of uncertainty.

• Shows Work Commitment: Sets high standards of performance; pursues aggressive goals and works efficiently to achieve them.

• Demonstrates Team-Oriented Characteristics: Fosters a positive and productive team environment by working effectively with others and offering help when able.

• Commits to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluated products, processes, and service against those standards; manages quality; improves efficiencies.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, medical preparations and other conditions common to an oncology/hematology clinic environment may occur. Work is performed in an office environment. Requires comfort in working in a team environment and having frequent interaction with staff, patients, visitors, and physicians.