Senior Traveling Clinical Specialist - 26532

Job Description

Job Description

Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Clinical Trial Specialist for a 6 Month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

As a Senior Clinical Trial Specialist, you work closely with Program Management to delivery high quality site monitoring and management for the Study Operations team within Clinical Shared Services. This will include clinical operations activities through the coordination of our global Clinical staff or within a geographic region. This role resides within our clients Neurovascular Division.

Essential Duties & Responsibilities:

• Conducting clinical research activities in accordance with SOPs and applicable regulations/guidelines.
• Supporting activities within various phases of clinical studies (i.e. study planning, site qualification and investigator selection, monitoring, closeout, etc.).
• Managing overall clinical site activities by providing oversight and guidance to CRAs for site activities in accordance with the Protocol, Monitoring Plan, Good Clinical Practice (GCP), ICH guidelines and federal regulations.
• Overseeing contract research organization (CRO) personnel site activities and overall vendor performance.
• Supporting the development of clinical study plans, presentations, study documents, contracts, development, and design of CRFs.
• Leading review of clinical data listings for completeness and accuracy and escalating issues to the CPM or above as appropriate.
• Providing co-monitoring and other shadowing opportunities to junior members of the team for training and development purposes.
• Developing and implementing enrollment and recruitment strategies.
• Maintaining a high level of professional expertise through familiarity with scientific literature, product portfolio and competitive environment.
• Building and maintaining great working relationships with KOLs and Study PIs.
• Reviewing monitoring visit reports and tracking resolution of action items.
• Identifying noncompliance and implementing preventative and corrective actions.
• Recommending process improvements to increase team efficiencies and effectiveness.
• Fully supporting the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements.

What you need

• A minimum of a bachelor's degree (B.S. or B.A.) required or equivalent in health/science field (RN, BSN, MBBS, DPharm).
• A Masters, MBA or PHD preferred.
• A minimum of 4 years' Medical Device or Pharma industry experience in a clinical study operations role (i.e. Clinical Trial Coordinator, Clinical Research Associate, or Clinical Trial Scientist) working directly for a Sponsor or CRO organization required.
• A minimum of 3 years of demonstrated independent site management responsibilities and data monitoring (source data verification) as a Clinical Research Associate (or equivalent title) experience required.
• Demonstrated independence conducting Site Qualification Visits, Site Initiation Visits, On-site AND Remote Interim Monitoring Visits.
• Demonstrated independence performing timely Study Start-up activities as well as the timely activation of sites to enroll, for both Central IRB sites and Local IRB sites.
• Working knowledge of GCP/ICH guidelines, federal and local regulations required.
• Experience performing Site Close-Out Visits preferred.
• ACRP CCRA Certification or SOCRA CCRP Category 3 Certification strongly preferred.
• Medical Device monitoring experience preferred.
• Global clinical trial experience and EUMDR working knowledge preferred.

Company DescriptionWhether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.

Benefits:
401(k) matching
Comprehensive dental, vision, and health insurance
Flexible schedule options
Health savings account
Life insurance
Paid time off
Professional development assistance
Employee assistance and discount programs
Referral program
Retirement plan
Tuition reimbursement

iMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential.

Experience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!

Contact us today to learn more:
*** Grand Rapids, Michigan: 616.254.8586
*** Tampa, Florida: 813.463.8850
*** www.impactbusinessgroup.com
*** Chat with us live: https://lc.chat/now/8608604/

Company Description

Whether you are seeking employment opportunities, or candidates for your open positions, iMPact Business Group is committed to providing our candidates and clients with unparalleled service and results. We leverage 200+ years of combined experience to develop Strategic Staffing Solutions that deliver best in class results while reducing overall costs associated with staffing initiatives. Our main focus areas of expertise are Information Technology, Engineering, Finance /Accounting, Business Administration/Process and Project Management.\r\n\r\nBenefits:\r\n401(k) matching\r\nComprehensive dental, vision, and health insurance\r\nFlexible schedule options\r\nHealth savings account\r\nLife insurance\r\nPaid time off\r\nProfessional development assistance\r\nEmployee assistance and discount programs\r\nReferral program\r\nRetirement plan\r\nTuition reimbursement\r\n\r\niMPact Business Group specializes in providing businesses with professional level Staffing (Contract/Project Staffing, Contingent/Direct Hire and Executive Retained Search). Since our inception, Impact Business Group has grown a recruiting and delivery platform that consistently exceeds our client's expectations. Besides providing you with training and the tools needed to ramp up quickly, we support you with a generous base salary, structured tenure pay increases and an uncapped commissions plan offers you an unlimited earnings potential. \r\n\r\nExperience the difference a results-oriented service organization can provide. Our clients, candidates and employees leverage an uncommon work ethic to deliver uncommon results. The philosophy is simple: integrate Motivated People and companies together - iMPact - the difference!\r\n\r\nContact us today to learn more:\r\n*** Grand Rapids, Michigan: 616.254.8586\r\n*** Tampa, Florida: 813.463.8850\r\n*** www.impactbusinessgroup.com\r\n*** Chat with us live: https://lc.chat/now/8608604/