Advanced Clinical

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.

The Medical Monitor (MM) is responsible for the delivery of medical monitoring services, including, but not limited to, working with clinical project teams to monitor the safety of ongoing studies, and support database locks. The MM will work with the clinical teams to review the safety data including review of MedWatch/CIOMS forms. This individual must have the ability to work and communicate efficiently with internal and external partners. This individual must possess strong verbal and written communication competencies as well as interpersonal skills with experience participating on project teams, coordinating safety activities, and adhering to tight timelines. The MM will attend regularly scheduled meetings as required and respond to site, sponsor and Health Authority questions. They will attend and present at Investigator meetings, review CRFs, present study updates as needed, train in-house staff and project teams, design and implement safety monitoring plans, conduct data base listings (DBL) final reviews, review blinded tables, listing & figures (TLFs), review protocol deviations, and participate in all DBL meetings as assigned. The MM will review final TLFs, work with the medical writer(s) to review & revise Clinical Study Report (CSR) documents, review discussion and conclusions, and participate in comment resolution meetings. The MM may present topline results to Sponsors or Competent Authorities. Other tasks may be required as determined by the project. The position can be remote with occasional face to face meetings dependent on business needs.

Responsibilities:

• Oversees and is responsible for the medical monitoring services on assigned projects.
• Oversees medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents.
• Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
• May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities.
• Ensures delivery of medical/clinical direction to investigative sites per contract deliverables.
• Prepares medical and safety plans for clinical trials/services.
• Reviews and analyzes safety and efficacy trends.
• Builds up, maintains, and develops the internal therapeutic training in their assigned studies.
• Assist with RFP/RFI completion and attend sales meetings as requested by Business Development
• Oversees collection, review, guidance and manages overall safety case processing as dictated by client contracts.
• Oversees reviews and directs medical and safety sections of regulatory document submissions.
• May participate in Investigator meetings Team Meetings, DSMB and Safety Review Meetings
• Contributes to the development of medical-related standard procedures and working activities.
• Facilitates collaboration and communication with medical/scientific personnel and ensures that the most current research information is accessible for review.
  
  

Qualifications:

• This individual requires an excellent understanding of the clinical/pharmaceutical process to effectively communicate and create required deliverables. Possesses advanced knowledge of, and ability to, apply GCP and all applicable regulations and guidelines. Possesses exceptional leadership skills and proven industry vision. Requires effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents. Must have the ability to understand complex clinical and statistical data and issues from an analytic standpoint. The MM must be a licensed Medical Doctor (MD) or Doctor of Osteopathy (DO) preferably with experience in Oncology. A minimum of five (5) years of industry experience and in-depth knowledge of, and experience as, a medical monitor for clinical trials (Phase I - III) is necessary.
• Education: Medical Doctor (MD) or Doctor of Osteopathy (DO) from an accredited university.
• Training: GCP (including 21 CFR 11), HIPAA – Privacy Rule and Protected Health Information.
• Certification: License to practice medicine.
• Experience: Minimum of two (2) years of clinical research and medical/safety management experience in the pharmaceutical industry
  
  

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.

Equal Employment Opportunity

It is Advanced Clinical’s practice not to discriminate against any Employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, physical or mental disability, medical condition, military or veteran status, or any other basis protected by applicable federal, state, or local law.

This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your Recruiter so that we can meet to discuss the appropriate alternatives available.