The Clinical Trials Medical Monitor (MM) will be responsible for identifying, developing, leading, and conducting program evaluation efforts for National Institute of Child Health and Human Development (NICHD), Division of Extramural Research (DER).
The MM will review and evaluate information relevant to the safety of products used in all clinical trials and selected studies.
The MM has the responsibility to review and evaluate information relevant to the product safety throughout the development and implementation of the protocol.
Specific Duties may include:
- Review, monitor, and report on subject safety, protocol and regulatory compliance, and data accuracy
- Provide expert input regarding clinical trial operations and procedures to NICHD staff who oversee networks or other cooperative agreements or contracts, as needed
- Review, evaluate, and provide expert consultation regarding safety issues for protocols funded on NICHD networks or other cooperative agreements or contracts
- Review and evaluate therapeutics and/or products used in clinical trials and selected studies as indicated by NICHD’s DER
- At the direction of NICHD staff, provide expert input to the network investigator team on clinical development plans, protocol designs, and risk assessments
- Assist in medical review, assessment, and interpretation of clinical and safety data when there is not an independent Data and Safety Monitoring Board (DSMB) and the work involves a contract or cooperative agreement
- Review and analyze safety and efficacy trends when there is not an independent Data and Safety Monitoring Board (DSMB)
- Conduct medical review of informed consent
- Review individual study medical monitoring plans and milestones to provide expert input to the Program Officer
- Provide expert consultation on clinical trial operations and procedures to Program Officer, Project Scientist, and DCC/site investigators
- Review clinical and medical data when evaluating reports of adverse events, protocol deviations, and unanticipated problems
- Review investigator brochure
- May assist with regulatory agency support, as needed
- Assist DER staff by providing clinical and regulatory advice and guidance on the extramural clinical research portfolio
- Serve as expert consultant to program staff, the Senior Policy Advisor for Clinical Research, DER Director, and senior NICHD leadership on clinical, ethical, policy, and regulatory issues related to the extramural clinical research portfolio
- Assist NICHD staff with coordination, oversight, and guidance on areas described above, as well as other areas such as data sharing and certificates of confidentiality
REQUIREMENTS
Skills and Experience
- Hold a M.D., PharmD, or equivalent with experience in biomedical research and pediatric and maternal health related safety issues
- Experience with the rigorous design and conduct of clinical research studies, particularly multicenter clinical trials testing drug, device, and/or behavioral interventions and comparative effectiveness research
- Demonstrate leadership in activities, as appropriate
- Ensure that products are technically competent, of high quality, and professional looking
- Demonstrate solid methodological approaches
- Present findings and handle client meetings, as appropriate
- Use innovative, creative approaches when necessary (to meet novel needs and/or solve problems
- Highly organized, efficient, and extremely detail-oriented
- Ability to prioritize among multiple tasks in a fast-paced, deadline-driven environment
- Ability to work productively in SharePoint to accomplish tasks
Preferred Skills
- Expertise in Obstetrics/Gynecolog
- Preference for a sub-specialty training in Maternal-Fetal Medicine and/or Pediatrics, as well as sub-specialty training in neonatology and/or pediatric critical care.
Benefits
Our employees are rewarded in many ways for their contributions to our mission, including competitive pay, exceptional benefits, and a range of work/life programs based on employment classification. Benefit offerings may include:
- Health Benefits – Health, Dental, and Vision
- Life, long-term disability, and other insurance products
- Health and Wellness Programs
- Flexible Spending and Health Savings Accounts
- Retirement 401K program
- Profit sharing and bonus program
- Paid and unpaid leave
- Professional development
- Flexible schedules and work location
Vetting and Hiring Process
It is the policy of Ripple Effect Communications, Inc. that:
- qualified applicants will receive consideration for employment without regard to race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits (Equal Opportunity Employer: minority/female/disability/veteran);
- employment eligibility will be verified using E-verify;
- applicants may be asked to participate in assessments during the interview process as described in our Informed Consent Policy; and
- applicants will not be reimbursed for any expenses associated with the interview process or relocation.
Position Overview
- Duty Location: Bethesda, Maryland
- Position Information: Part-time
- Vacancies:1 opening
- Travel Required:Occasional Travel for Meetings
- Relocation Expenses:No relocation expenses may be authorized for this position
How To Apply
https://ripple-effect-communications-inc.workable.com/jobs/828688/candidates/new
Closing date
Reference: https://www.workable.com/j/C6F033E65A
