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
Oversees and reviews site activities for clinical trials via on-site monitoring visits and/or in-house assessments according to the trial-specific monitoring plan. Oversees clinical site activities. Monitors trial records to verify the protection and well-being of study subjects and that reported trial data is adequate, complete and verifiable from source document data. Reviews site compliance with protocol, Good Clinical Practice (GCP), FDA regulatory requirements, and Standard Operating Procedures (SOPs). Frequent travel to study sites is expected.
Responsibilities
- Performs pre-study, initiation, interim monitoring and close out visits according to applicable SOPs, GCP and FDA Guidelines.
- Monitors clinical studies at a site level, including the review of case report forms (CRFs) to ensure adherence to the current protocol and consistency and scientific validity of the data as verified against source document data.
- Manages all aspects of a clinical study at assigned clinical trial sites to ensure subject safety and well-being, adherence to appropriate safety regulations and data integrity.
- Provides technical, scientific and operational guidance to study site personnel on the protocol.
- Assists with the tracking and reporting of enrollment and works with site to identify enrollment issues, barriers and strategies.
- Implements project specific processes and tools.
- Responsible for maintaining or gathering site/project specific information as directed by sponsor and project management.
- Coordinates the collection and approval of essential and regulatory documents and maintenance of site study documentation.
- Assists other team members with site-specific issues, acting as liaison between study staff and project staff.
- Must be able and willing to travel as the project requires.
- Performs other tasks as directed by line management or project leadership.
Requirements
Education:
- This position requires a B.S./B.A. in a health related or scientific field and a minimum of 2 years of experience in clinical research, or equivalent combination of education and experience.
Experience:
- Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance.
- Experience in ophthalmology preferred.
- Some experience in field monitoring preferred.
- Ability to travel 60% to 70% of time.
Skills:
- Highly customer service oriented.
- Quality of interactions demonstrates an emphasis on developing and retaining strong relationships internally and externally.
- Competent communication (both written and verbal), personable, able to develop a positive rapport with clinical sites.
- Demonstrates analytical and problem-solving skills and appropriate judgement regarding issue identification and escalation.
- Strong attention to detail.
- Competent computer and organizational skills.
- Works well independently and as part of a dynamic project team.
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.
The pay range for this role is: 100,000 - 120,000 USD per year (United States).
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