Overview
Provides support to Study Management and other study team members. Responsible for in-house site management. Contributes to protocol-level and investigator-related clinical trial documents, study supplies and vendor information. Keeps study-related essential documentation current and filed. Facilitates collection and review of essential documents, budgets/contracts and IRB documentation on behalf of sponsors and sites. Serves to support standardized, anonymized, and objective grading of study images by trained graders. Produces accurate and unbiased image grading.
Responsibilities
Supports grading, quality checks, and quality control of Cornea and/or Retinal reads from the imaging types (according to assigned study, but not limited to):
Spectral Domain Optical Coherence Tomography (SD-OCT)
Color Fundus Photography (CFP, UWF or 7-field)
Optical Coherence Tomography Angiography (OCTA)
Slit Lamp Imaging
Fundus Autofluorescence (FAF)
Fluorescein Angiography (FA)
Microperimetry (MP)
Specular Microscopy (SM)
Anterior Segment Optical Coherence Tomography (AS-OCT)
Complete Training and maintain up-to-date training record:
GCPs
Reading Center SOPs
Clinical management system training with Reading Center Project Manager or designee
Ophthalmic software training with Reading Center Project Manager or designee
Study Specific Protocols
Study Specific Image Reading Protocol
Analyze ophthalmic images and identify/characterize features and pathologies according to reading center protocols
Participate in adjudications with other reader(s)
Record data in eCRFs
Participate and attend Reading Center Meetings, as needed
Contribute to quality improvements in grading and imaging protocols
Perform site training and certification to site coordinators, photographers/technicians, PIs
Issues/clears queries with sites and reviews responses
Track all critical aspects of the study and communicate information to the study team, escalating issues as appropriate
Responsible for collection and tracking of essential documents to/from sites
Assist with the preparation of study materials such as newsletters, study logs, note to files, etc
Generate draft meeting agendas, minutes and action items for study-related meetings, as needed
Coordinate study team activities on behalf of study management
Work on assignments requiring judgment and initiative. Understand implications of work and make recommendations for solutions
Perform other tasks as directed by line management or project leadership
Requirements
Education:
BA/BS in the science/health care field, nursing degree, or equivalent combination of education and experience
Experience:
At least 2 years of clinical research coordinating experience or experience working in a contract research organization (CRO), pharmaceutical, or biotechnology company is preferred
Competent computer skills including MS Office Suite
Experience working with eTMF and EDC systems is preferred
Skills:
Customer service oriented
Demonstrates 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 remotely in a fast-paced environment that requires effective multi-tasking and ability to easily adapt to changing priorities
Works well as part of a dynamic project team, actively supporting other team members and identifying opportunities to contribute
Proficient technical software and computer processes
Effective and efficient with time management
Physical Requirements
Position requires: ordinary ambulatory skills and physical coordination sufficient to move about conference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.