INTEGRATED DIAGNOSTICS JOB OPPORTUNITY
Clinical Research Associate (CRA)
About Integrated Diagnostics.
Integrated Diagnostics is a venture-funded biotechnology company founded in 2009 that is focused on applying cutting-edge protein technologies to advance healthcare. The goal of the company is to develop molecular in vitro diagnostic (IVD) tests to interrogate biological circuits contributing to the pathogenesis of Alzheimer’s Disease and lung cancer. The company’s IVD product development effort is powered by proteomicsTM, integrating the knowledge of systems biology with the cutting-edge technology of multiple reaction monitoring mass spectrometry to identify and quantify blood proteins in diverse molecular pathways to discriminate between disease states.
The management team is deploying the resources of its $30 million Series A investment from InterWest Partners, the Wellcome Trust and the BioTechCube Luxembourg to partner with academic experts and consortia to expedite its product development processes and the commercialization of new molecular diagnostic tests in a CLIA-certified clinical laboratory. To help achieve its corporate milestones and goals, Integrated Diagnostics is seeking a highly motivated professional experienced in clinical operations to manage translational medicine studies for IVD test development involving multi-center collaborations in the United States, Canada and Europe.
Reporting to the Director of Clinical Operations, the Clinical Research Associate (CRA) coordinates research and administrative strategies for the management of clinical research. He/she is responsible for coordinating and monitoring clinical trials, both directly and indirectly with contract research organizations (CROs). This is an in-house CRA, and will work as part of an interdisciplinary team and coordinate all activities required to initiate, monitor and complete clinical programs, both domestically and internationally.
- Participate in the design and review of clinical protocols, case report forms (CRFs), associated study documents, monitoring plans, and regulatory submissions and reports in collaboration with clinical management.
- Provide regular clinical status information and to team members, including attending required meetings and following-up on action items.
- Ensure adherence to protocols, procedures, and project plans.
- May participate in identification, evaluation, and selection investigative sites.
- Assists and/or manage activities and interactions with CROs and/or vendors.
- Maintains all relevant documentation and communications as part of study files.
- Performs other job related duties as assigned.
- May act as a point contact for regionally based CRAs, and coordinates day-to-day activities of clinical sites.
- Ability to coordinate or manage multiple projects across multiple centers.
- Coordinates clinical site monitoring activities, and may participate is site monitoring associated with initiation, interim, close out, and audit visits as required.
- Adhere and assists with clinical operations and project specific quality documents (for example: SOPs, work plans/practices, training guides).
- Reviews study data and resolution of queries, compile data for data review, create tables and graphs under appropriate guidance, and assist with the preparation and review of clinical study reports.
- May travel to study sites based on project needs.
- BA/BS in a clinical, scientific, or related field.
- At least 2 years of CRA experience (regional or in-house). Experience as a Study Lead and/or Study Manager is helpful.
- Strong working knowledge of medical/scientific terminology and knowledge of FDA regulations and GCP guidelines is required.
- Excellent planning and problem solving skills.
- Excellent communication skills and ability to communicate effectively with all levels of the organization.
- Ability to travel up to 30%, based on project needs.
- Proficiency with Office Suite and standard computer programs required.