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Sr. Clinical Research Associate (CRA), Oncology- Massachusetts Job Boston United States,  

Posted on : 13 April 2017

Project Description

Sr. Clinical Research Associate (CRA), Oncology- Massachusetts-CLI005715DescriptionMerck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company  one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.The Sr. CRA acts as primary site contact and site managerthroughout all phases of a clinical research study, taking overall responsibilityof allocated sites.Duties and responsibilities include, but are not limited tothe following:- Develops strong site relationships and ensures continuity ofsite relationships through all phases of the trial.- Performs clinical studysite management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs,Local Laws & Regulations, Protocol, Site Monitoring Plan and associateddocuments.- Gains an in-depth understanding of the study protocol and relatedprocedures.- Coordinates & manages various tasks in collaboration withother sponsor roles to achieve Site Ready.- Participates & provides inputson site selection and validation activities.- Performs remote and on-sitemonitoring & oversight activities using various tools to ensure:- Datagenerated at site are complete, accurate and unbiased- Subjects  right, safetyand well-being are protected- Conducts site visits including but not limitedto validation visits, initiation visits, monitoring visits, close-out visitsand records clear, comprehensive and accurate visit & non-visit contactreports appropriately in a timely manner.- Collects, reviews, and monitorsrequired regulatory documentation for study start-up, study maintenance andstudy close-out.- Communicates with Investigators and site staff on issuesrelated to protocol conduct, recruitment, retention, protocol deviations,regulatory documentation, site audits/inspections and overall site performance.- Identifies, assesses and resolves site performance, quality or complianceproblems and escalates per defined CRA Escalation Pathway as appropriate incollaboration with CRM, PLM and RCPM.- Manages and maintains information anddocumentation in CTMS, eTMF and various other systems as appropriate and pertimelines.- Contributes strongly to CRA team knowledge by acting as processSubject Matter Expert (SME), sharing best practices, making recommendations forcontinuous improvement and providing training as appropriate/required.- Supports and/or leads audit/inspection activities as needed.- Mentors / buddiesjunior CRAs on process/study requirements and performs co-monitoring visitswhere appropriate*This is a remote/Home-based position.QualificationsEducation:- Required: BA/BS- Preferred: BA/BS withstrong emphasis in science and/or biologyRequired:- Minimum of 4 years of direct site management (monitoring) experience in aBiopharmaceutical, Pharmaceutical or CRO company.- Experience monitoring Oncology clinical studies- Travel: 65%-75%- Valid driver's licenseCORE Competency Expectations:- Fluent in Local Languages andEnglish (verbal and written) and excellent communication skills, including theability to understand and present technical information effectively.- Excellent understanding andworking knowledge of clinical research, phases of clinical trials, currentGCP/ICH & country clinical research law & guidelines.- Excellent understanding ofGlobal, Country/Regional Clinical Research Guidelines and ability to workwithin these guidelines.- Demonstrated ability tomentor/lead- Hands on knowledge of GoodDocumentation Practices- Proven Skills in SiteManagement including independent management of site performance and patientrecruitment- Demonstrated high level ofmonitoring skill with independent professional judgment.- Good IT skills (Use of MSoffice, use of various clinical IT applications on computer, tablet and mobiledevices) and ability to adapt to new IT applications on various devices.- Ability to understand andanalyze data/metrics and act appropriatelyBehavioral Competency Expectations:- Effective time management,organizational and interpersonal skills, conflict management, problem solvingskills- Able to work highlyindependently across multiple protocols, sites and therapy areas.- High sense of accountability/ urgency. Ability to set priorities and handle multiple tasks simultaneouslyin a changing environment.- Works effectively in a matrixmulticultural environment. Ability to establish and maintain culturallysensitive working relationships.- Demonstrates commitment toCustomer focus.- Works with high quality andcompliance mindsetOur employees are the key to our company s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at Firm Representatives Please Read Carefully:Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.For more information about personal rights under Equal Employment Opportunity, visit:EEOC PosterEEOC GINA Supplement Merck is an equal opportunity employer, Minority/Female/Disability/Veteran  proudly embracing diversity in all of its manifestations. Job: Clinical Research Monitor(CRA)Job Title:Sr. Specialist, Clinical ResearchPrimary Location: NA-US-MA-BostonOther Locations: NA-US-Massachusetts, NA-United StatesEmployee Status: RegularTravel: Yes, 75 % of the TimeNumber of Openings: 1Company Trade Name:Merck Nearest Major Market: Boston Job Segment: Oncology, Clinic, Clinical Research, Medical Research, Research Associate, Healthcare, Research


Boston, MA, US

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