Job Details
Description
Primary Duties and Responsibilities
Understand and interpret clinical trial study protocols to design and develop calendars. Understand and interpret clinical trial agreements and sponsor budgets to develop site budgets for the protocol.
Design and develop case report forms for clinical trial study protocols
Develop a familiarity with Advarra’s Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in the design and development of calendars, budgets, financials and case report forms.
Work closely with reporting manager to complete daily/ weekly calendars, budgets, financials and/or case report forms design to meet with pre-determined quality criteria.
Understand and utilize internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked and completed.
Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols.
Position Requirements:
Knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research.
Expected to work independently, as well as in a team environment.
Good organizational and administrative abilities
Familiarity with MS Office and various business software
Preferred: 0-1 year work experience in job areas such as: o Clinical trial coordinator at site
Clinical data management
Pharmacovigilance
Records management
Key Personal Attributes:
Highly personable nature that fosters teamwork
Excellent communication skills – oral as well as written
High energy and positive attitude towards working in a culturally diverse environment
A passion for ensuring outstanding customer support with a solutions-oriented attitude.
Proactive and takes ownership in all tasks from start-to-finish.
Working Hours:
Monday-Friday 9:00 a.m. to 6:00 p.m
Physical and Mental Requirements
Sit or stand for extended periods of time at stationary workstation
The employee must occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus
This position requires regular oral/written interaction with clients, team members and management
EEOStatement
Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed, and employees are treated during employment without regard to any of these characteristics.
Discrimination of any type will not be tolerated.
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