Study Coordinator

Southern Research•Birmingham, AL

3h•Onsite

About The Position

This position is responsible for performing diverse duties to support both government and commercial studies within the organization. This position is responsible for providing study support by assisting in the planning, scheduling, execution, and closure of study tasks; and compiling, managing, and reviewing study data and documentation. The Study Coordinator will work closely with the Principal Investigator, Co-Principal Investigator, Study Director/Scientist, Project Managers, fellow Study Coordinators, assigned project team members, and associated management for the program. Study Coordinators are expected to share knowledge gained through experience with their peers.

Requirements

Bachelor’s degree with 5 years of program/study coordination experience.
Ability to learn and utilize specialty software applications (e.g., laboratory information management systems, Provantis, MS Project).
Good grasp of the fundamental concepts, practices, and procedures of microbiology/ virology/ immunology/ biology.
Effective verbal and written communication skills including correct grammar, spelling, and punctuation.
Detail oriented; possess good planning and organizational skills; inquisitive; takes direction well.
Proficiency with Microsoft Office applications (Windows, Word, Excel, Access, etc.).
Strong organization skills and capable of multi-tasking.
Ability to read, understand, retain, and apply knowledge of Good Laboratory Practices (GLP) and other study requirements.

Responsibilities

Interacts with assigned Subject Matter Expert, Study Director, and Project Manager to effectively execute, conduct, and report for all assigned studies.
Assists in the initiation or amendment of studies and drafting of Animal Care Use Protocols (ACUP), Biological Project Registration (BPR), study protocols/work requests, tracks study samples throughout study lifecycle.
Responsible for Provantis study setups; distributing to appropriate teams following Study Director/Responsible Scientist review and approval.
Primary POC for all Provantis protocol setup inquiries from internal users (i.e., Laboratory Animal Resources (LAR), pathology, etc.) and works with Study Directors/LAR to ensure proper Provantis setup prior to study start. Available for critical study phases to address any Provantis issues in real time.
Tracks progress of studies to ensure timely execution of activities and communicates any changes to study timelines to internal and external teams.
Works with Study Director/Responsible Scientist in preparation and review of data; ensures quality control is performed and corrections are made prior to submission to report writing team.
Assures adherence to study schedules by interacting effectively with and providing information to various staff and client groups; prompts individuals and groups of needed results and approaching deadlines; and coordinates needs of one group or person with those of another group or person.
Formats study report from finalized protocol and protocol amendments and works alongside Study Director or Responsible Scientist in preparation of data, tables, and graphs, as necessary.
Demonstrates strong organization and communication skills while assisting with multiple projects in various stages of completion.
Works with the Study Director/Responsible Scientist to compile, summarize, maintain, and archive study data, including review of study data for missing, inaccurate, or improbable results.
Assists with communicating schedule and procurement requests.
Maintains study records and archive study data and reports upon study conclusion.
Observes appropriate safety and study requirements by reading, understanding, and following Standard Operating Procedures (SOP), applicable regulatory requirements, and study protocols.
Performs other coordination duties as required by study, including entering study rooms as necessary.