Project Specialist - Reading Center

We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with.
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 aboutconference 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.
Originally posted on Himalayas