Job description

Position: Clinical Research Coordinator

Job Description Summary: Provides support to Study Management and other study team members. Tracks and maintains study and investigator-related clinical trial documents, files, study supplies, and vendor information. Keeps study related documentation current and filed. May also be responsible for coordination of supplies to clinical sites, and contacting sites as directed. May facilitate collection and review of essential documents and IRB submissions on behalf of sponsor and site.

Key Responsibilities:

§ Tracks multiple aspects of the study and communicates information to the study team, escalating issues as appropriate.

§ Provides administrative support for amendments, trackers, and follow-up with sites.

§ Develops and provides reports to update study management and summarize study progress and status.

§ Responsible for site support during study start-up. As directed by the study team, communicates with site staff regarding the collection and status of essential documents, study supplies, mass communications, enrollment survey follow-up, and other study related information and actions.

§ Assists study team in collection and tracking of essential documents, IRB submissions, procurement and shipment of supplies to sites.

§ Assists with review of both internal and external documents, including essential documents and IRB applications.

§ Maintains clinical trial master files (TMF and eTMF) and keeps all documentation current. Assists with inventory of the TMF/eTMF.

§ Provides meeting agendas, minutes and action items for study related meetings.

§ Coordinates study team activities on behalf of study management.

§ Performs other tasks as directed by line management or project leadership.

Minimum Requirements:

§ This position requires a B.S./B.A. (health related or scientific discipline preferred) or minimum of 4 years administrative or technical/scientific experience, or equivalent combination of education and experience.

§ Competent computer skills including MS Office Suite.

§ Experience working in a regulated environment such as a CRO or pharmaceutical company is preferred.

Skills & Attributes:

• Customer service oriented.
• Demonstrated good communication skills (written and verbal).
• Attention to detail.

· Manner of interactions demonstrates an understanding of the value of developing positive relationships.

· Ability to plan and organize information and activities as directed by a Study Manager or team member.

· Able to resolve routine problems and elevate issues appropriately.

· Able to work in a fast paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities.

· Proficiency in some software system(s) as appropriate for needs of department.

· Possesses active listening skills and proactively seeks clarification and additional information as needed.

• Works well as part of a dynamic project team, actively supporting other team members and identifying opportunities to contribute.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Application Question(s):

• What industries have you worked in?
• How many years of experience do you have in a CRO setting?

Experience:

• in Ophthalmology industry: 2 years (Preferred)

Work Location: Remote

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