Clinical Research Coordinator CareerscapeClinical Research CoordinatorBoston, MA$50,000–$65,000 / yearTemporaryThe Clinical Research Coordinator will manage the day-to-day operational requirements of assigned studies, including patient enrollment, protocol adherence, data collection, and regulatory documentation. The position requires direct interaction with study participants, sponsor representatives, and institutional review boards, and demands a working knowledge of FDA regulations and Good Clinical Practice guidelines.
Clinical Documentation Specialist Integrated Resources, IncClinical Documentation SpecialistLexington, MassachusettsTemporaryJob DescriptionTitle: Clinical Documentation SpecialistLocation: Lexington, MADuration: 6 months (possible extension)JOB SUMMARY:• Manages the Trial Master Files (all of the documents that support the clinical trials-everything that the FDA and regulatory agencies review)• Support group for clinical, data managing, medical writing, safety, clinical supplies (Global Clinical Development Operations)JOB REQUIREMENTS:• Processing, filing and tracking of Trial Master File (TMF) documents (paper and/or electronic) in accordance with study-specific TMF Roadmaps• Performing quality checks of TMF documents as needed• Providing oversight of TMF quality checks performed by functional areas and/or CRO's• Assisting with audit and inspection preparation as applicableMUST HAVE:• 2 years minimum experience doing anything associated with TMF (Trial Master Files) or Clinical Documentation• GCP Experience preferred• clinical experience• CTA/CRA experience OK• Experience with using an electronic document management system and proficient in excel necessaryQualifications• 2 years minimum experience doing anything associated with TMF (Trial Master Files) or Clinical Documentation• GCP Experience preferred• clinical experience• CTA/CRA experience OK• Experience with using an electronic document management system and proficient in excel necessary Clinical Documentation SpecialistA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.