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Sr. Clinical Trial Management Associate

Integrated Resources, Inc

Foster City, California

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Biology, Case Report Form (CRF), Clinical Research, Clinical Trial Management, Contract Research Organization (CRO), Cross-Functional, Establish Priorities, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Healthcare, ICH Regulations, Information Technology & Information Systems, Informed Consent, Interpersonal Skills, Microsoft PowerPoint, Microsoft Word, Multitasking, Presentation/Verbal Skills, Regulations, Rehabilitation Nursing, Site Evaluation, Strategic Planning, The Joint Commission (TJC), Writing Skills
LOCATION
Foster City, California
POSTED
3 days ago
Sr. Clinical Trial Management AssociateIntegrated 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.Job DescriptionTitle: Sr. Clinical Trials Management AssociateDuration: 6 MonthsLocation: Foster City, CA, United StatesJob Responsibilities And SkillsMust meet all requirements for CTMA position and have demonstrated proficiency in all relevant areasMust be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and proceduresParticipates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teamsMust be able to anticipate obstacles and proactively develop solutions to achieve project goalsMust have a general understanding of functional issues and routine project goals from an organizational perspectiveMay participate in abstract presentations, oral presentations and manuscript development.Interfaces with individuals in other functional areas to address routine study issuesAbility to develop tools and processes that increase measured efficiencies of the projectMay be asked to assist in the training of CTMAs and CPAsAssists in CRO or vendor selectionCoordinates CROs or vendorsAssists in the setting and updating of study timelinesMust be able to participate in departmental or interdepartmental strategic initiatives under general supervisionAssists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepanciesMay conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as requiredAssures site compliance with the protocol and regulatory requirementsDrafts and coordinates review of protocols, informed consents, case report forms and monitoring plansExcellent verbal, written, interpersonal and presentation skills are requiredKnowledge of FDA and or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studiesWorking knowledge and experience with Word, PowerPoint and ExcelQualificationsMinimum Education And ExperienceAt least 3+ years of experience and a BS or BA in a relevant scientific disciplineAdditional InformationKind Regards,Sabanaaz ShaikhClinical RecruiterIntegrated Resources, Inc.IT Life Sciences Allied Healthcare CROGold Seal JCAHO Certified for Health Care Staffing"INC 5 0 0 0's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)

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Integrated Resources, Inc

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