Clinical Research Associate

Employer
Kelly
Location
Weymouth, Massachusetts
Posted
Apr 21, 2021
Closes
May 05, 2021
Ref
43c859849c13
Organization Type
Corporate
Kelly is seeking a Clinical Research Associate for one of our biotech clients in Cambridge, MA.
  • 6 months with likelihood of extension to 12 months
  • Pay $33/hr
  • Possibility of conversion, but individual would have to undergo standard process for FTE (apply + interview, etc.)
  • Post-COVID, partly onsite
  • Position Title: Clinical Research Associate
  • Title of Position Reporting To: Study Support Team Lead
  • Work Location: Cambridge, MA - Lexington, MA
  • Function: Clinical Program Support
  • Department: Global Clinical Development and Operations


Primary Duties
The in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the the Clinical Project Manager(s). The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager. The CRA performs work within established protocols under general supervision.

Responsibilities
Study Start-Up Activities:
  • Assists the study team(s) to deliver the clinical study within agreed timelines.
  • Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.)
  • Provides oversight of Clinical CRO Investigator background checks.
  • Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary.
  • Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.
  • Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items.
  • Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.
  • Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System.
  • Assists and/or participates in planning and conduct of Investigator's Meetings as necessary.

Study Maintenance Activities:
  • Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced.
  • Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager.
  • Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.
  • Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements.

Study Close Out Activities:
  • Assists study team with preparation for audits/inspections
  • Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager.
  • Liaises with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly.

Development Tasks
Development tasks may be assigned to a CRA as appropriate
upon discussions with manger:
  • Assist in providing oversight of CRO activities regarding country and site specific informed consent documentation tracking, finalization and approval.

Departmental Tasks:
  • Maintains knowledge and act as team super user or subject matter expert for related systems and processes.
  • Maintains up to date training record attending internal/external training(s) as necessary.
  • Participates in inter-departmental workgroups to create or enhance processes.


Education and Experience Requirements
  • Bachelor's degree required
  • 1-3 year's experience in similar/relevant field (eg.Sponsor, CRO, Clincal trial Vendor, Clincal Coordinator, etc.)

Key Skills, Abilities, and Competencies
Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Relevant experience in clinical research or related field
  • Adequate Good Clinical Practice training
  • General knowledge of regulatory requirements and guidelines governing clinical research
  • Comfortable with technology and ability to learn new systems quickly
  • Strong knowledge of MS Word, Excel, PowerPoint and Outlook
  • Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines
  • Must be able to professionally interact and communicate with visitors, vendors, and individuals at all levels of the organization
  • Must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands
  • Ability to work successfully within a cross-functional team
  • Understanding how their input and role coordinate more effective business practices
  • Complexity and Problem Solving
  • Ability to take ownership and manage tasks as well as communicate effectively
  • Ability to lead others to drive deliverables forward
  • Must be able to work in a fast paced environment
  • Demonstrate ability to prioritize multiple competing tasks
  • Ability to work with minimal supervision and complete tasks according to deadlines


Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.
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