Company

KCR

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Medical Monitor

Publication

2022-05-16

Company description

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

 
Medical Monitor
Location: US (home-based)
 

Clinical Research Physician is responsible for medical oversight towards assigned study protocols, provides medical expertise to cross functional study team, including support to safety cases processing and ensuring medical integrity of the data.

Responsibilities:

  • Oversees study protocols, reviews, and provides medical input to essential documents (study protocols, informed consent forms, project management plans, case report forms, safety management plan, data management plan, data review plan, clinical monitoring plan)
  • Develops medical monitoring plan(s)
  • Provides medical support to facilitate ethics/regulatory approvals
  • Provides medical coverage during study meetings (kick-off, Investigators’ Meeting, DSMB)
  • Leads therapeutic area/indication training for the project clinical team
  • Creates expertise and opinion in SOP writing/updating in the fields of Clinical SOP
  • Provides ongoing medical support to study team and investigators, including management of eligibility issues
  • Coordinates feasibility studies
  • Provides medical inputs in processing of safety cases
  • Reviews SAE reports and issues SAE queries in scope of medical consistency
  • Assesses relatedness and expectedness of the event
  • Ensures integrity of medical data and safety signals detection
  • Prepares reviews of clinical data in accordance with the Medical Monitoring Plan in cooperation with Data Management and Biostatistics Department
  • Participates in blinded/unblinded data review meetings and review of clinical study report
  • Performs special projects as requested by Management in the process of development of company’s service offering
  • Provides medical support to Sales and Proposal Department: general medical study feasibility analysis, defining study execution assumptions.
  • Contacts opinion leaders in assigned country in order to gather the required information for projects

Requirements:

  • Medical University Degree
  • At least four years of clinical research experience
  • Experience working on clinical studies, across different phases of drug development
  • Experience or interest in haemato-oncology or immunology therapeutical area
  • Proven organizational and analytical skills
  • Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
  • Excellent knowledge of spoken and written English
 
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs. To show that you are appreciated in our team, while working at KCR you will be provided with: 
 
  • Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry;
  • An open culture with a flat hierarchy and direct access to the Management to share ideas and implement change;
  • Possibility of getting involved in multinational studies;
  • Onboarding process to enable you fast takeover of duties;
  • Peer Buddy Mentor who will introduce you to the organization;
  • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed;
  • Empowering workspace, offering opportunities to share ideas and influence company services development worldwide;