Advarra® is the premier provider of institutional review board (IRB) services for human subjects research in North America. Fully accredited by AAHRPP, Advarra serves the world’s leading pharmaceutical, biotechnology, medical device, and contract research organizations, as well as academic medical centers, health systems, investigative site networks, and therapeutic research consortia.
We are looking for talented individuals to join our Consent Form team!
These positions are based in Seattle, WA, Blue Ash, OH or Columbia, MD.
General Summary: The Sr. Coordinator, Consent Form Development (CFD), develops consent forms and other materials used in the conduct of human subjects research. In addition, the Sr. Coordinator facilitates training on consent related forms and materials and completes projects as defined by management.
Principal Duties & Responsibilities
Provide an informed, accurate pre-review of new and revised consent forms and other research-related materials.
In pre-reviewing this material or creating it, apply controlled documentation and collaborate with Board members and staff to meet performance standards for quality, efficiency, and service.
Develop and demonstrate the ability to prepare the team’s key deliverables.
Identify, communicate, and implement strategies to improve quality, efficiency, and service standards and/or operational procedures.
Regularly fulfill responsibilities requiring specialized consent-related and operational expertise that elevate the performance of the team and organization. These responsibilities may include (but are not limited to) effective coordination and/or completion of the following:
Research and interpretation of consent-related issues, as requested by the Board or staff.
Training and guidance for team members, other staff, and external clients.
Coaching and mentoring of team members as assigned by Supervisor.
Collaboration across departments or teams to resolve complex problems or issues.
Other activities with team-level or companywide visibility that require in-depth understanding of controlled documentation and organizational structure.
Bachelor’s degree or equivalent combination of education and/or experience
CIP or completion of CIP within one (1) year of eligibility
2+ years of demonstrated proficiency in editing consent forms and other consent documents.
Experience fulfilling responsibilities with team-wide visibility and impact, such as routinely providing training and guidance to the CFD team or other groups
Demonstrated ability to perform as an expert in either Primary or Secondary development functions, and able to demonstrate competency in operational processes and provide appropriate insight to the alternative in either development function
Exhibited proficiency in all major CFD related projects
Demonstrated strong business acumen, and is able to guide the team towards business goals
Knowledge, Skills, Abilities
Communication skills (including writing, editing, and oral communication)
Research and fact-checking skills
Problem-solving and analytical skills
Project coordination/organization skills
Interpersonal and customer-service skills
In-depth, working knowledge of matters regarding consent for human subjects research
Writing, editing, and fact-checking
Proficiency in using the company’s database and other systems
Familiarity with scientific/medical terminology preferred
Ability to extract essential details from technical documents
Ability to manage various editing projects under tight deadlines
Ability to work independently
Ability to make consistent judgment calls
Ability to evaluate workload of team and prioritize tasks
Ability to coach and mentor peers
Ability to communicate effectively with customers and members of other Advarra departments
Physical and Mental Requirements
Sit or stand for extended periods of time at stationary work station
Regularly carry, raise, and lower objects of up to 10 Lbs.
Learn and comprehend basic instructions
Focus and attention to tasks and responsibilities
Verbal communication; listening and understanding, responding and speaking
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.
Internal Number: SRCOO01148
About Advarra, Inc.
With a legacy stretching back to 1983, Advarra® is the premier provider of institutional review board (IRB), institutional biosafety committee (IBC), and research quality and compliance consulting services in North America. Fully accredited by AAHRPP, Advarra serves the world’s leading pharmaceutical, biotechnology, medical device, and contract research organizations, as well as academic medical centers, health systems, investigative site networks, and therapeutic research consortia.To address the increasingly complex needs associated with research, Advarra leverages exceptional client service, innovative technology, and robust global regulatory expertise. Advarra also provides deep experience across all major therapeutic areas and continues to pioneer highly specialized review services for areas such as oncology and neurology.