Research Publication Regulatory Coordinator (Remote) (Part-time)

Please note this position is a 12 month Contract and is a Part-Time Remote position. No Corp to Corp or H-1B.
Please note this position is flexible with the hours, prefer 4 hours a day, if a meeting in the morning at 8am they would need to be able to attend the 8am meeting in EST.

Qualifications:

· A minimum of an associate degree is required. A bachelor’s degree is preferred.

· Experience with publication management systems (e.g., PUBSRAT, PubPro) is highly preferred

· Basic understanding of research methodologies (in clinical/health preferred)

· Knowledge in regulatory and/or compliance in health care industry (e.g., clinical research, trials, health outcomes research) is highly preferred

· Basic understanding of scientific publication methodologies preferred

· Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Adobe) is required

· Ability to learn specialized computer (or Web-based) software used for document approval processes, training curricula, and other applications

· Prior experience with creating standardized operating procedures is preferred

· Must have excellent time management skills

· Must have good verbal and written communication and interpersonal skills

· Must have strong organizational skills, along with excellent judgment and reasoning abilities.

· Must be a strong team player with the ability to coordinate with client

· Ability to multi-task and work under minimal supervision, in a dynamic, fast-paced, multicultural, international environment is required.

Job Description:

This role is located in Cincinnati Ohio and will operate under the direct supervision of the Client's Director-- providing full-time (40 hours per week) process administration support.

Basic responsibilities

· Administer the approval process of research protocols using PUBSTRAT, including basic quality control, according to standardize procedures

· Administer the approval process of scientific publication submissions using PUBSTRAT, including basic quality control, according to standardized procedures

· Maintain entries into research process trackers and summarization of information for reporting to senior leadership

· Assist in development and updating/maintenance of PUBSTRAT administrators process guidelines

· Serve as main point of contact with the vendor of the PUBSTRAT platform

· Document Preparation: memorandums, correspondence, and/or presentations as needed.

· File management (e.g., Microsoft 365 Teams, SharePoint, Word, Adobe)

· Assist in the critical review and proofread of standardize process documents

· Assemble relevant data, generate reports, compile statistics or information as directed (as needed)

· Conduct debarment/exclusion checks

· Assist in development and maintenance of training curricula in ComplianceWire

· Flexibility to accommodate a changing work schedule and sensitivity to international time zones is required.

· Develop in-depth knowledge of department’s research processes, policies, and procedures

· Acquire knowledge of department organizational structure

· Collaborate with administrative staff colleagues to ensure office efficiencies

· Maintain Client’s objectives

· Assist with Purchase Order requests and processing

· Provide other administrative support as assigned by the Associate Director.

Candidates must provide their phone number. Job reference number is A5658.