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Freelance Senior Clinical Research Associate

TFS HealthScience

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Category:
Research and Development

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Job Description:

TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions. As part of our SRS/FSP team, you will be dedicated to one sponsor. Please, keep in mind that this is a 1 year contract Freelance opportunity for approximately 0.1 FTE -0.2 FTE.

Job Responsibility:

  • Monitor clinical trials on-site and remotely in accordance with TFS/client SOPs, FDA regulations, and GCP/ICH guidelines
  • Review CRFs (paper or electronic) and subject source documentation for validity and accuracy
  • generate queries to resolve data issues
  • Identify site problems or deficiencies and report them to management through trip reports, memos, and communication with the Project Manager or Lead CRA
  • Initiate corrective actions as directed by the supervisor
  • Contribute to Ethics Committee/IRB application submissions and prepare required documentation in collaboration with the CTA and as directed by the Lead CRA/Project Manager
  • Participate in contract handling and negotiation under direction of the Lead CRA/Project Manager
  • Set up the Investigator Site File (ISF) and Study Master File (SMF), or support the CTA in doing so, and distribute materials to investigational sites
  • Collaborate with the study team on SMF maintenance
  • Order, ship, and reconcile clinical investigational supplies for study sites, if applicable
  • Coordinate ordering and shipment of study supplies to sites
  • Prepare and submit status reports as directed by the Lead CRA/Project Manager
  • Review and support site staff in maintaining the SMF
  • Review Informed Consent Forms for essential elements and protocol compliance
  • Update CTMS with site and study information
  • Audit data in tables and text of clinical summaries (as applicable)
  • Assist in preparing study documentation—such as CRF Completion Guidelines, patient diaries, and study participation cards—by reviewing for accuracy and completeness
  • Prepare check requisitions for sponsor Project Manager approval, when applicable

Requirements:

  • Bachelor’s degree, preferably in life sciences or nursing, or equivalent
  • Minimum of 2 years of experience working as a CRA (in oncology)
  • Ability to work in a fast-paced environment with changing priorities
  • Understanding of basic medical terminology and science related to assigned drugs and therapeutic areas
  • Solid understanding of Good Clinical Practice (GCP) regulations and ICH guidelines
  • Ability to work independently and within a team/matrix organization
  • Excellent written and verbal communication skills
  • Strong organizational skills
  • Ability and willingness to travel
What we offer:
  • competitive compensation package
  • comprehensive benefits
  • opportunity for personal and professional growth in a rewarding environment

Additional Information:

Job Posted:
December 12, 2025

Employment Type:
Parttime
Work Type:
Remote work
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