Medical Writer Clinical Trials

The Medical Writer Clinical Trials is responsible for analyzing, writing and editing technical documentation summarizing clinical study ideas in to protocols and resulting publications as well as writing summarizing other scientific matters. This role will contribute to developing and implementing comprehensive workflows and project planning to ensure ongoing clinical trial compliance across the Disease Specific Oncology Research Programs. This includes, but is not limited to, overseeing and driving the clinical research trials development and analysis process to final deliverables in a timely and effective manner. Will collaborate and communicate with teams of investigators and research staff to ensure continual process development and improvement, always emphasizing clarity in training and implementation with the highest standards of integrity.

Responsibilities

A day in the life of a Medical Writer Clinical Trials at Hackensack Meridian Health includes:

• Assists the principal investigator in the preparation of proposed clinical trials by developing trial protocols and associated documents, seeks input from all collaborating departments who will provide resources during study and ensures appropriate departments are notified and given a copy of proposed trial, feasibility including scientific merit and accrual potential.
• Collects and compiles data, conducts analysis and summarizes findings. Prepares manuscripts and reports for internal (marketing or product documentation) or external (regulatory submissions, medical journals, academic conferences or presentations) use.
• Verifies technical details of protocols and publications with medical or research personnel.
• Reviews existing documentation for accuracy and clarify and makes revisions as needed. May draft standard responses to common press or customer inquiries.
• Handles basic issues and problems, and refers more complex issues to higher-level staff.
• Develops workflows for all aspects of study conduct for site staff and patients to ensure the highest quality work.
• Oversees reports and assists with ongoing analysis of performance and workflows.
• Provides efficient updates on progress to the Research Director with respect to assigned projects, project plans, trial and timeline management, and quality standards.
• Ensures potential study risks are escalated to management as appropriate.
• Implements solutions for streamlining and accelerating the development of Investigator Initiated Trials with an eye towards increasing accrual to clinical trials, data cleaning, data quality, and trial completion.
• Provides regular reports to the PI regarding study progress and challenges and work with the PI to address any problems that arise.
• Develops relationships and create points of contacts with new physician referral networks and pharmaceutical/biotech companies. Confer with health care professionals to determine the best recruitment practices for studies.
• Maintains professional expertise through familiarity with therapeutic area and clinical research literature.
• Oversees and drives projects from concept to final deliverables.
• Works daily in collaboration with other research team members including but not limited to Principal Investigators, Research Nurse Coordinators, Sponsors, Regulatory Specialists, Contract Research Organizations, and employees of Hackensack Meridian Health.
• Ability to sit and concentrate at a computer workstation for a minimum of 4 hours at a single sitting.
• Other duties and/or projects as assigned.
• Adheres to HMH Organizational competencies and standards of behavior.

Qualifications

Education, Knowledge, Skills and Abilities Required

• Bachelor's degree in a scientific or medical discipline with at least 5 years of experience in clinical healthcare environment. Solid knowledge of Good Clinical Practice guidelines and Protection of Human Subjects regulations.
• Strong attention to detail and customer service focus is required.
• Excellent medical writing, communication, organizational, presentation, documentation, and interpersonal skills are required.
• Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
• Expertise in Microsoft Office including Word, Excel, and PowerPoint, including the ability to solve technical problems with documents and templates; proficiency with Access and a variety of database applications; experience with EndNote, Adobe Acrobat, and Visio.
• Review and comply with all relevant HMH and Business Unit policies and procedures, and local, state, and Federal laws and regulations.
• Mandatory education on human subject research and GCP (CITI Training and Certification).
• Possesses beginning to working knowledge of subject matter.

Education, Knowledge, Skills and Abilities Preferred

• Higher Education Degree (M.S., PhD, MD).
• Knowledge of clinical trials and the regulation (local, state, and federal) of such.
• Familiarity with basic scientific and healthcare principles and terminology.
• Ability to work in a fast-paced environment and manage competing tasks and demands.

Licenses and Certifications Required

• Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC) and/or SOCRA Certification at time of hire or to obtain within 1 year(s) of hire.