JFK Johnson Rehabilitation Institute
MEDICAL WRITER CLINICAL TRIALS
JFK Johnson Rehabilitation Institute, Hackensack, New Jersey, us, 07601
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MEDICAL WRITER CLINICAL TRIALS
role at
JFK Johnson Rehabilitation Institute
Medical Writer Clinical Trials – Hackensack University Medical Center, Hackensack, New Jersey
Overview Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better – advancing our mission to transform healthcare and serve as a leader of positive change.
Responsibilities
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, abstracts, 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 clarification 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 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 regarding study progress and challenges and works with the PI to address any problems that arise.
Develops relationships and creates points of contacts with new physician referral networks and pharmaceutical/biotech companies. Confers 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.
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.
Minimum of 5 or more 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.
Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
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.
Excellent written and verbal communication skills.
Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
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.
Compensation Minimum rate of $63.05 Hourly. HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
Benefits In addition to our compensation for full-time and part-time (20+ hours/week) positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
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MEDICAL WRITER CLINICAL TRIALS
role at
JFK Johnson Rehabilitation Institute
Medical Writer Clinical Trials – Hackensack University Medical Center, Hackensack, New Jersey
Overview Our team members are the heart of what makes us better. At Hackensack Meridian Health we help our patients live better, healthier lives — and we help one another to succeed. With a culture rooted in connection and collaboration, our employees are team members. Here, competitive benefits are just the beginning. It’s also about how we support one another and how we show up for our community. Together, we keep getting better – advancing our mission to transform healthcare and serve as a leader of positive change.
Responsibilities
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, abstracts, 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 clarification 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 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 regarding study progress and challenges and works with the PI to address any problems that arise.
Develops relationships and creates points of contacts with new physician referral networks and pharmaceutical/biotech companies. Confers 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.
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.
Minimum of 5 or more 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.
Ability to work independently, or in a team, and handle multiple deadline driven tasks in a dynamic environment is essential.
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.
Excellent written and verbal communication skills.
Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.
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.
Compensation Minimum rate of $63.05 Hourly. HMH is committed to pay equity and transparency for our team members. The posted rate of pay in this job posting is a reasonable good faith estimate of the minimum base pay for this role at the time of posting in accordance with the New Jersey Pay Transparency Act and does not reflect the full value of our market-competitive total rewards package.
Benefits In addition to our compensation for full-time and part-time (20+ hours/week) positions, HMH offers a comprehensive benefits package, including health, dental, vision, paid leave, tuition reimbursement, and retirement benefits.
Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to age, race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, breastfeeding, genetic information, refusal to submit to a genetic test or make available to an employer the results of a genetic test, atypical hereditary cellular or blood trait, national origin, nationality, ancestry, disability, marital status, liability for military service, or status as a protected veteran.
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