OPKO Health, Inc. is a publicly traded healthcare company engaged in the discovery, development, and commercialization of diagnostic technologies, therapeutic initiatives, and proprietary drug products. OPKO Health is currently recruiting for a Clinical Trial Associate for its Miami, FL office.
Duties and Responsibilities
Develop, send, collect, review, and process clinical trial related documents (i.e. informed consent forms, FDA forms, curriculum vitae, financial disclosure forms, etc.) in compliance with requirements set forth by regulatory agencies (e.g., FDA, TPD, EMEA, ICH-GCP, SOPs and working practice guidelines, etc.)
Set-up, maintain, oversee and reconciles trial master files
Maintain tracking tools and spreadsheets of required investigative site essential documents and contact information
Assist with the preparation of study amendments, model informed consent forms, laboratory manuals, and other clinical trial related documents as assigned
Maintain and coordinate generation of clinical trial status reports and tracking spreadsheets and/or databases.
Generates and reviews management reports from internal tracking systems at requested intervals.
Works with QA to develop SOP’s regarding TMF, Records Retention Room and Shared Drive posting of clinical trial documents.
Participate in cross functional internal study team meetings and take minutes as requested.
Will take direction and instruction from Lead Clinical Trial Specialist.
Minimum of two years’ experience in the pharmaceutical industry, supporting clinical trial conduct in an operational capacity, with demonstrated thorough knowledge of the operational aspects of pharmaceutical trials.
Bachelor’s degree in life sciences or equivalent experience required.
Basic knowledge of ICH-GCP guidelines and relevant regulations as governs essential documents.
Ability to work in a team environment, demonstrate detailed oriented skills, technically astute, and possess solid communication skills are required competencies.
Must have experience and be proficient with MS Office, Electronic Document Management Systems, and DIA TMF Reference Model.
Experience with Veeva is a plus.
We offer a competitive salary and excellent benefits package, including 401k match, paid disability and life insurance, and excellent medical and dental insurance.
OPKO Health, Inc. is a publicly traded healthcare company engaged in the discovery, development, and commercialization of diagnostic technologies, therapeutic initiatives, and proprietary drug products.