Research Associate (31093) in Woodbridge, Virginia at GI Alliance

Research Associate (31093)
Job DetailsJob Location: Potomac Beauregard - Alexandria, VA 22311; Potomac Fairfax - Fairfax, VA 22033; Potomac Woodbridge - Woodbridge, VA 22191
Position Type: Part Time
Job Shift: Day
Description

Description

POSITION SUMMARY:
Research Associates contribute to Urology Alliance’s growing research department. Research Associates support the Clinical Research Team with subject recruitment, visit procedures, data entry and communications with patients, and investigators, and other interesting research related roles.
ROLE QUALIFICATIONS:
Experience, Education, and Skills

Must be willing to gain a thorough knowledge and follow strict adherence of all clinical study protocols.

Develop an understanding of and demonstrate Good Clinical Practices (GCPs), learn and comply with all FDA clinical trial and IRB rules and regulations

Effective time management and the ability to prioritize work

Excellent communication skills and the ability to interact with all levels of management, staff, and physicians in person, virtually, and in writing

Ability to be flexible with the day-to-day job requirements to facilitate a successful workflow in clinic

ESSENTIAL JOB RESPONSIBLITIES:

Review and follow Urology Alliance Standard Operating Procedures

Read and understand specific requirements of each study protocol and informed consent form

Works with study coordinators and other research team members to complete protocol specific procedures and documentation

Assists in clinic and protocol administration duties including but not limited to:

• Conduct screening procedures and other visit procedures in a timely and accurate manner
• Provide instructions to patients to ensure proper protocol compliance
• Distribute and instill study medications in compliance with protocol randomization requirements
• Learn and understand lab procedures and obtain and process study related lab specimens according to the study specific manuals (lab and procedural)
• Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirements

Conduct screening procedures and other visit procedures in a timely and accurate manner

Provide instructions to patients to ensure proper protocol compliance

Distribute and instill study medications in compliance with protocol randomization requirements

Learn and understand lab procedures and obtain and process study related lab specimens according to the study specific manuals (lab and procedural)

Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirements

• Perform study-specific readings and measurements including but not limited to:

Perform study-specific readings and measurements including but not limited to:

Vital signs

ECG

Urine Pregnancy Test

Uroflow, PVR, urinalysis, cystoscopy

Photography and videography

Catheter placement

Reports irregular readings and measurements to Investigator and Lead Study Coordinator

Package and ship laboratory specimens to study-specific destinations

Complete applicable training requirements and ongoing education as required

Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.

Communicate with and support patients and their families as necessary.

Must have or gain knowledge of relevant software/programs

Assist with the development of source documents and phone screen tools

Manage ancillary supply inventory and assist with drug accountability as needed

Maintain HIPAA compliant communication and confidentiality, at all times

Performs other duties as assigned

Performance Requirements:
Knowledge

Knowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.

Understanding of medical terminology.

Skills

Ability to use multi-line phone systems and basic computer systems.

Interpersonal and communication both with internal staff and external customers.

Skill in evaluating and implementing study protocols and budgets.

Skill in reading medical chart terminology.

Time Management.

Abilities

Ability to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.

Elicit appropriate information for patients to clinic staff.

Ability to read and understand information and ideas presented in writing.

Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.

Reporting to this position: No direct reports at this time - can change as department grows

Physical Demands and Work Environment:
The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be provided to enable individuals with disabilities to perform the essential functions:

Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up-to 20 pounds.

Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment.

Qualifications

Qualifications

Must be willing to gain a thorough knowledge and follow strict adherence of all clinical study protocols.

• Develop an understanding of and demonstrate Good Clinical Practices (GCPs), learn and comply with all FDA clinical trial and IRB rules and regulations

• Effective time management and the ability to prioritize work

• Excellent communication skills and the ability to interact with all levels of management, staff, and physicians in person, virtually, and in writing

• Ability to be flexible with the day-to-day job requirements to facilitate a successful workflow in clinic