Clinical Research Associate

Job Type Full-time Description

JOB SUMMARY:

The role of Clinical Research Associate (CRA) is to support ongoing and upcoming clinical trials (Phase 1 through Phase 4). The position will monitor patient recruitment, enrollment, data and study-related information related to clinical trial sites and study participation. Ensures the investigators adhere to the established clinical protocols, regulatory requirements and Good Clinical Practice, and provides input into data validation. Provides monitoring of patient data and study-related information from source documents, research records, and site visits where applicable. Travel to clinical sites will be necessary.

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

• Ensures study-related communication to internal and external study team: assists in preparation, distribution and tracking (as needed) of clinical trial correspondence, newsletters, and IDE Safety Letters.
• Contributes to specified periodic clinical trial meetings (e.g., investigator meetings, study team meetings, CRA and CRO meetings) as requested by arranging logistics, managing preparation of necessary materials, training clinical site personnel on study procedures, and being responsible for recording and distributing minutes.
• Assists with site feasibility, qualification and selection process; responsible to bring study sites ready for activation, conducts site monitoring visits, manages study monitoring schedule, audits CRFs for conformity to source documentation, and conducts study close-out visits according to study monitoring plans.
• Contributes to target timelines and oversees adherence to timelines. Ensures site team members complete action items in a timely manner.
• Maintains audit-ready clinical trial documentation and study status: manages and tracks regulatory documentation, IDE Safety Letter distribution, Confidentiality Agreements and Clinical Trial Contracts, as well as other clinical trial documents.
• Ensures that necessary study supplies are available at sites as necessary, coordinating with appropriate vendors as needed: (i.e., Case Report Forms, Study Manuals, lab kits, drug supplies, lab supplies, etc.); manages review and tracking of shipment, destruction/return.
• Manages and helps create clinical trial tracking metrics and reporting for internal and external collaborators.

Requirements

KNOWLEDGE, SKILLS AND ABILITIES:

• The candidate must have experience as a CRA including the ability to interact effectively with investigators and cross-functional teams.
• Possesses medical and technical aptitude with current knowledge in relevant therapeutic and product areas and a command of the medical and scientific areas assigned.
• In depth understanding of ICH GCP Guidelines and other local or international guidance, regulation and codes of practice related to the execution of clinical trials, preferably ophthalmic devices.
• Ability to take and maintain initiative, prioritize, organize, and problem solve independently with the use of critical thinking skills.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree or equivalent; or a LVN, RN, PA, or other licensed health care professional degree.
• Minimum 5 years of experience directly supporting clinical research trials or similar experience in a medical/scientific area.
• Experience with electronic data capture preferred; experience with eCTD filing preferred.
• Clinical Research Associate certification and/or Good Clinical Practice training certification desirable.
• Professional use of the English language, both written and oral, is required.

PHYSICAL REQUIREMENTS:

• This position requires up to 70% travel.
• Must be able to remain in a stationary position at least 50% of the time.
• Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
• Occasionally lift up to 25 pounds. This may be performed with reasonable accommodation.
• View and type on computer screens for long periods of time.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.

Salary Description $99,000 - $110,000/year