Senior Clinical Research Associate - Remote

Location
London
Salary
Competitive
Posted
Jul 01, 2022
Closes
Jul 14, 2022
Ref
3308
Function
Analyst, Research
Industry
Science
Hours
Full Time
UK Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Orphan Reach, part of the Emmes group is a full-service Niche CRO which operates globally in rare disease. The purpose of Orphan Reach is to expedite the development of orphan drugs and facilitate patient access to treatments which can improve the quality of life of patients and their families. By driving best practice our team can provide continued, seamless, high-quality support to biopharmaceutical companies throughout any stage of the orphan product lifecycle, a service that has not previously been available.

Primary Purpose

The Senior Clinical Research Associate may be assigned to both national and international clinical studies and is the main link of communication between study site and Sponsor or Sponsor representative.

The Senior Clinical Research Associate is responsible for the tasks related to site selection, initiation, monitoring and closure of study sites. All study related tasks will be conducted according to good Clinical Practice, documented procedures, and regulatory requirements.

Responsibilities
  • Preparing and conducting initial feasibility activities to identify suitable potential study sites
  • Preparing and conducting site selection and initiation visits, routine monitoring and closeout and submitting visit reports and up-to-date site status reports to the Study Team Leader
  • Preparing applications to regulatory authorities and ethics committees
  • Negotiating contracts with host organizations & local/central laboratories/pharmacy etc.
  • Coordinating and being responsible for ensuring completion and provision of approved study documentation e.g. CRFs, patient diaries, study participation cards, Quality of Life forms, etc.
  • Preparing study documents: Monitoring Plans, Source Data Verification Plans etc.
  • Assisting in the planning and participating in Investigator meetings when required
  • Attending study team/sponsor meetings as required
  • Responsible for study site management during the study process, training, and re-training site staff as necessary
  • Organizing/relaying all needs of study site staff to conduct the trial to acceptable standards, ordering and coordinating study supplies as necessary
  • Assisting and supporting the data validation procedure, ensuring data standards are met
  • Providing relevant quality essential documentation to the Trial Master File, reviewing the relevant Study Site Files periodically for accuracy and completeness
  • Maintaining all electronic documents with appropriate files names according to the Orphan Reach naming conventions
  • Maintaining adequate level of training, ensuring that all training is completed in a timely manner and documented evidence is filed according to Orphan Reach procedures
  • Participating in audits and inspections when requested to do so
  • Participating in the preparation of audit/inspection responses
  • Participating and contributing to in-house clinical operations meeting
  • Providing ad hoc support to the Project Managers
  • Contributing to the quality of the clinical procedural documentation, providing input and feedback to the Quality Assurance Department as a subject matter expert.


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.