Integrated Resources, Inc.
Clinical Research Specialist
Integrated Resources, Inc.
Job Title: Clinical Research Specialist Location: Irvine, CA Duration: 12 month Position Description The Clinical Research Specialist supports the planning and conduct of clinical studies and ensures compliance to the study protocol, ICH-GCP guidelines, applicable regulatory standards, and companies Standard Operating Procedures. The Clinical Research Specialist is responsible for site management activities such as collecting, reviewing, and tracking essential documents, reviewing the data, and ensuring site compliance. Position Responsibilities Contribute with protocol development including compilation of feedback from the cross functional team and drafting study documents Contribute in the development and review of Clinical Investigational Plans with statistical justifications, patient informed consent, case report forms, clinical study material, and clinical databases in collaboration with cross functional teams Interface with physicians and study support personnel Contribute in the management of interaction between sites, vendors, and cross functional team members Assist with investigator and site selection process Participates in one or more clinical studies from preparation, activation, enrollment, submission, maintenance, and study closure phases Contribute in the management of investigative sites from study start up through close out Contribute to the development and maintenance of the study budget Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring, staff, CROs, and core laboratories Responsible for Device Accountability and Reconciliation activities Contribute in the preparation of clinical protocols and regulatory submissions including 510(k), PMA, IDE, and others Contribute in the development and completion of regulatory reporting requirements and internal reporting requirements Review clinical monitoring reports Contribute in the overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines, and policies; e.g., monitoring reports, device tracking, and CAPA tracking systems Evaluates clinical and adverse event data for completeness during the conduct of the study and for completion of clinical study reports Collaborate with monitor for closure of site action items, collection of source documents and regulatory items Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports, and implementing corrective actions Participate in clinical site audit activities including pre-inspection training at clinical sites and within the department Ensure general logistical support for meetings, such as document preparation and taking meeting minutes Coordinate physician meetings such as Investigator Meetings, Clinical Events Committees, and Data Monitoring Boards Maintain CTMS and study trial master file and other project tracking tools Ensures set up of Trial Master File (TMF) folder structures in document repositories and files all essential clinical study documentation in TMF for one or more studies per standard operating procedures and study plans Performs related duties as assigned Basic Qualifications BA/BS degree in science or health care area Required Education BA/BS degree in science or health care area Required Years of Experience 2 or more years of clinical research experience required with medical device experience desired Required Knowledge Good working knowledge of MS Excel, PowerPoint, Word, and internet search engines Working knowledge of the Code of Federal Regulations 21 CFR, ISO 14155, Medical Device Directive (EC), and Good Clinical Practices (GCP) Proficient knowledge of medical terminology Desired/Preferred Qualifications Excellent written, oral, and interpersonal communication skills Ability to work independently and effectively on cross-functional teams Ability to comply with written procedures, instructions, SOPs and other documents Results and solution oriented Customer focused Demonstrated ability to make timely and well-reasoned decisions and adapt to shifting priorities and competing demands Masterâ€™s or Advanced Degree preferred Medical device experience preferred Physical Job Requirements Ability to travel less than 10%, ability to work as Irvine based/office based employee Standing, sitting, walking, light lifting, are regularly required Extended periods of time doing computer-based work are regularly required
Integrated Resources, Inc.
Website : http://www.irionline.com/
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. With today’s growing demand for talented and well qualified professionals, it’s more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth. IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ.