Study Coordinator

2 days ago

Middlesbrough, Middlesbrough, United Kingdom Medica Research Full time

Medica Research is an exciting new approach to delivering clinical research in primary care

We are looking for a number of study coordinators to support us with development of new research delivery sites

The Study Coordinator is a site based role responsible to administer, maintain and co-ordinate all aspects of clinical trials conducted at the site in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). They will also be the main point of contact between the site and central team.

Primary Responsibilities

Clinical

· Carry out clinical assessments (ECG, Blood Pressure Monitoring, Blood draws, Spirometry etc.) as per trial protocol

· Care and Maintenance of all study related medical equipment

· Collection and processing biological samples

· Patient care and communication

· Drug accountability

· Contemporaneous study data capture

Administrative

· Data entry to Electronic Data Capture Systems within agreed timelines and Data query management.

· Attendance and participation in study meetings (SIV, PSV etc.), minute taking and distribution

· Assist with the Ethics / Regulatory Submissions

  • Set up and maintenance of Investigator Site File (ISF)
  • Managing and maintaining study documents & trial supplies e.g., Patient Information Sheets, Patient Diaries, Lab Kits etc.
  • Preparing essential clinical trial documentation, distributing, tracking and filing of documents.
  • Collection of patient invoices and arrange reimbursements.
  • Complete all mandatory training

Communication

· Maintain a highly effective working relationship with the practice manager, PI, SI and other practice staff

· Communicate key study information, updates, timelines and targets in a clear and concise manner

· Schedule patient visits and arrange patient transportation

· Schedule sponsor/CRO representative visits.

· Maintain confidentiality

Planning and Organisation

· Plan and prioritise own work activities and site schedule

· Create and maintain schedule of visits for each study

· Effective diary management

· Update training and delegation logs for all members of the study team

· Maintain electronic records and shared drive

Management and Reporting

· Management of all studies at site

· Ensure study targets are achieved

· Weekly reporting on key study metrics

· Proactive and positive approach to challenges

· Occasional travel to other Medica Research network sites

Person specification

Essential

  • Life science/Healthcare Degree or Prior Experience as a Healthcare Assistant
  • Team player
  • Excellent written and Verbal communication skills
  • Proficient in IT and data management skills
  • Excellent organisational and time management skills

Desirable

  • Prior experience in Primary/Secondary care and General Practice
  • Nursing Degree
  • Willing to travel/ Full Driving License
  • Prior Clinical Research Experience

Job Type: Full-time

Pay: £25,000.00-£38,000.00 per year

Benefits:

  • Company pension
  • Flexitime

Work Location: In person

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