Cooper Companies
Clinical Trial Assistant - Contract
Cooper Companies, Pleasanton, California, United States, 94566
Job Description
CooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week 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.com.
Job Summary:
Assists the Clinical Operations team in tracking and filing of clinical trial documentation and managing investigational product traceability to support the conduct of clinical trials during product research and development of ophthalmic medical device (Contact Lens). May also work with clinical partners, investigative sites and CROs.
Responsibilities
To provide general administrative support to the Clinical Operations team for the completion of all required tasks to meet departmental and project goals. To support the Clinical Operations team with execution of ongoing studies. To be familiar with ICH GCP, appropriate regulations, relevant SOP's, and internal tracking systems. To assist Clinical Operations team with setting up, organizing, maintaining, and archiving of clinical study documentation (e.g., Master Study Files, email correspondence, training records, etc.), including preparation for internal/external audits and final study document/Trial Master File reconciliation. To process Data Collection Forms i.e., log in, track, and perform quality control, as appropriate, for studies. To assist in quality control of clinical study documentation (e.g. Trial Master Files, CRFs, Monitoring , Regulatory, etc.). To provide general logistics support to assist with ordering/dispatching and tracking of study materials (e.g. investigative product, study binders, etc.) as appropriate. To file study correspondence, internal documentation, CRFs, etc., as appropriate, in the Trial Master File in a real-time and ongoing basis. CooperVision's management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.
Travel:
None Qualifications
Knowledge, Skills and Abilities:
Experienced in organizing, ability to manage multiple tasks, and meticulous attention to detail. Skilled in logistics and inventory tracking. Good written and verbal communication skills. Proficient written and spoken English. Computer literacy: e.g. Microsoft Word, Excel, Outlook. Work Environment:
Normal office environment, clinical inventory, and ophthalmic clinical exam rooms Sedentary to light physical effort necessary to perform the job Extensive contact with employees and outside researchers Occasionally lift to 50 lbs Experience:
Research or health care related academic or work experience preferred. Previous administrative work experience is preferred. Prior experience working as a CTA, a plus. Education:
Either relevant work experience or associate degree in a health science field preferred.
Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $24.03 and $29.29 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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LI-SD1
CooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week 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.com.
Job Summary:
Assists the Clinical Operations team in tracking and filing of clinical trial documentation and managing investigational product traceability to support the conduct of clinical trials during product research and development of ophthalmic medical device (Contact Lens). May also work with clinical partners, investigative sites and CROs.
Responsibilities
To provide general administrative support to the Clinical Operations team for the completion of all required tasks to meet departmental and project goals. To support the Clinical Operations team with execution of ongoing studies. To be familiar with ICH GCP, appropriate regulations, relevant SOP's, and internal tracking systems. To assist Clinical Operations team with setting up, organizing, maintaining, and archiving of clinical study documentation (e.g., Master Study Files, email correspondence, training records, etc.), including preparation for internal/external audits and final study document/Trial Master File reconciliation. To process Data Collection Forms i.e., log in, track, and perform quality control, as appropriate, for studies. To assist in quality control of clinical study documentation (e.g. Trial Master Files, CRFs, Monitoring , Regulatory, etc.). To provide general logistics support to assist with ordering/dispatching and tracking of study materials (e.g. investigative product, study binders, etc.) as appropriate. To file study correspondence, internal documentation, CRFs, etc., as appropriate, in the Trial Master File in a real-time and ongoing basis. CooperVision's management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.
Travel:
None Qualifications
Knowledge, Skills and Abilities:
Experienced in organizing, ability to manage multiple tasks, and meticulous attention to detail. Skilled in logistics and inventory tracking. Good written and verbal communication skills. Proficient written and spoken English. Computer literacy: e.g. Microsoft Word, Excel, Outlook. Work Environment:
Normal office environment, clinical inventory, and ophthalmic clinical exam rooms Sedentary to light physical effort necessary to perform the job Extensive contact with employees and outside researchers Occasionally lift to 50 lbs Experience:
Research or health care related academic or work experience preferred. Previous administrative work experience is preferred. Prior experience working as a CTA, a plus. Education:
Either relevant work experience or associate degree in a health science field preferred.
Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $24.03 and $29.29 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.
#
LI-SD1