Clinical Specialist - Contract
Clinical Specialist - Contract
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Job Description
CooperVision a division of CooperCompanies (NASDAQ:COO) is one of the worlds leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable twoweek and monthly contact lenses all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism presbyopia and childhood myopia; and offers the most complete collection of spherical toric and multifocal products available. Through a combination of innovative products and focused practitioner support the company brings a refreshing perspective to the marketplace creating real advantages for customers and wearers. For more information visit www.coopervision.
Job Summary:
Support the of multisite postmarket clinical studies in accordance with regulatory requirements and CooperVision internal procedures. Utilize optometric and clinical research skills to direct the conduct of highquality clinical investigations and monitor research results. Work in cooperation with Clinical Affairs Regulatory Affairs Quality Assurance Clinical Research Organizations (CROs) vendors and sites.
Responsibilities
- Accountable for support of multicenter clinical studies including:
- Manages the development and implementation of clinical study protocols in conjunction with CRO. Serves as clinical study expert for sites/investigators/CRO. Hosts study meetings for clinical sites/investigators. Develops and delivers additional training materials and other site support materials as appropriate.
- Assists with data monitoring report generation and review. Utilizes data management and analytical skills to interpret monitoring reports and identify potential issues.
- Manages review and appropriate internal and externals communication of adverse events protocol deviations product defects etc.
- Writes and editsstudy documents scientific and progress reports abstracts and papers as appropriate.
- Builds and maintains relations with external vendors (CRO equipment vendors etc. and clinical sites/investigators.
- Understands basic regulatory requirements related to medical devices (GCP/ IRB / FDA & ISO standards/ EU MDD etc) and applies under direction of clinical management. Supports clinical trial filing and reports to regulatory authorities.Participates in fulfilling R&D clinical regulatory requirements by interfacing with Regulatory Affairs and Quality Assurance to fulfill R&D regulatory obligations.
Qualifications
Knowledge Skills and Abilities:
- Great communication and interpersonal skills; able to work within teams of internal and external parties (CRO vendors clinical sites etc. and interact professionally in the medical environment.
- Ability to understand and resolve complex problems proactively and independently under uncertain and evolving regulatory and complicated external stakeholder environments.
- Ability to learn product knowledge and technical materials search and read clinical/medical/research literature.
- Knowledge of contact lens clinical evaluation techniques contact lens clinical performance and clinical trials.
- Excellent written and spoken English and strong medical/technical writing abilities.
- Strong selfmotivation and organizational skills
Work Environment:
- Remote position with flexible hours to support the nature of the job.
- Occasional travel <20 to CooperVision R&D clinical sites or CRO
Experience:
- 5years experience in clinical research
- Experience in contact lens industry or in a clinical setting with contact lens trials ispreferred
Education:
- Doctoral degree in optometry/ophthalmology
- Masters or PhD (or equivalent experience) in related discipline
We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.
For U.S. locations that require disclosure of compensation the starting base pay for this role is between $60.24 and $80.32 per hour and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.
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Required Experience:
Unclear Seniority
Employment Type
Full-Time
