What are the responsibilities and job description for the Research Medical Director (Part TIme) - Maitland, FL position at Advanced Dermatology and Cosmetic Surgery?
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The Medical Director of Clinical Research is responsible for providing clinical and medical expertise across all phases of clinical trials. Working in close partnership with the Clinical Research Administrator, this role ensures patient safety, protocol integrity, data quality, and compliance with regulatory and ethical standards. The role serves as a key liaison between the investigators and cross-functional teams to support the successful execution of clinical trials.
KEY RESPONSIBILITIES
Medical Oversight & Patient Safety
Serve as the primary medical contact for clinical trial sites and safety queries.
Conduct ongoing medical review of clinical trial data, including adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
Ensure timely medical assessment and reporting of safety data to internal and external stakeholders.
Alongside the Clinical Research Administrator, ensure trials are conducted in accordance withICH-GCP, local regulations, and internal SOPs.
Support preparation and review of clinical and safety sections of regulatory documents (e.g., INDs, CTAs, CSRs).
Maintain awareness of current dermatologic clinical practice and evolving regulatory expectations related to dermatology studies.
Protocol Development & Scientific Leadership
Provide medical insight during protocol feasibility and site selection processes.
Review medical components of clinical study documents, including the Investigator Brochure (IB), Clinical Study Report (CSR), and Informed Consent Forms (ICFs).
Provide guidance on the use of clinical photography, lesion tracking, histopathology requirements, and biomarker collection (e.g., skin biopsies).
Review subject enrollment eligibility and diagnostic accuracy of dermatologic conditions.
Cross-functional Collaboration
Work closely with clinical operations, data management, and compliance teams
Participate in clinical trial team meetings and provide medical expertise throughout the trial lifecycle.
Support training of clinical site staff and internal teams on the medical and scientific aspects of the study.
Regulatory & Ethical Compliance
Ensure studies are conducted in accordance with ICH GCP, local regulations, and company SOPs.
Support regulatory filings, including IND/CTA submissions and responses to health authority queries.
Contribute to the development of safety narratives and clinical sections of regulatory documents.
KNOWLEDGE, SKILLS, AND ABILITIES
Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards, and the ability to actively apply that knowledge in the performance of all job duties
Knowledge of electronic health record access-level privileges and responsibilities, and the ability to perform electronic health record job duties for this position within the parameters of the access level assigned
Ability to practice confidentiality and follow HIPAA regulations with patient information
Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information/trade secrets of the organization
Ability to recognize a problem and effectively problem-solve, using guidance from the provider and/or management when necessary
Knowledge of medical terminology and ability to use appropriately
Ability to manage time efficiently, prioritize, multi-task, and adapt to change
Ability to maintain high level of accuracy in all documentation and in the performance of all job duties
Ability to perform the essential job duties within the scope of education and training
Skilled in typing/keyboarding; skilled in using computers
PROFESSIONALISM
Project a professional manner and image, including proper workplace attire and grooming standards; exhibitprofessional conduct at all times
Adhere to ethical principles and core ADCS values; follow all ADCS policies
Treat all patients and staff with respect, compassion, and empathy, recognizing and respecting cultural diversity
Demonstrate initiative and responsibility for actions
Work as an effective team member
Maintain a strong record for attendance and punctuality in arriving at work
Enhance skills through continuing education
Education: MD, DO, or equivalent medical degree; board certification preferred.
Experience:
Minimum 3–5 years of clinical research experience
Prior experience as a clinical research physician strongly preferred.
LANGUAGE/COMMUNICATION REQUIREMENTS
Ability to read and interpret work-related documents such as reports, communications, safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine reports and correspondence
Ability to listen, speak, and interact effectively with all patients and co-workers, adapting communication for optimal understanding
Ability to practice professional telephone etiquette and techniques on all calls
MATHEMATICAL SKILLS
To the extent necessary for the performance of the job duties of a Medical Assistant – such as pharmacology-related job duties (mixing medications, Botox, lidocaine, etc.) – the ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
REASONING ABILITY
Ability to understand and follow instructions, both written and verbal. Must possess strong problem identification/resolution skills and be able to manage complications involving several variables.
WORK ENVIRONMENT AND CONDITIONS
Work is performed in a medical clinic and offices. Involves frequent telephone and in-person contact with patients, staff, vendors, providers, and management. Requires some flexibility in working hours. Requires the ability to work in a demanding environment and to effectively resolve conflicts as they arise. Occasional weekend work may be required. Occasional travel to clinical sites, investigator meetings, or conferences may be required.
PHYSICAL DEMANDS
Work requires sitting with prolonged periods of walking and standing. Tasks require grasping, fine finger and hand dexterity, and computer keyboarding and mouse usage. This position requires that the employee be able to push/pull, reach, bend, and kneel/crouch/squat. Occasional lifting up to 25 pounds. Normal vision required, with or without corrective lenses. Normal hearing is required.
The Medical Director of Clinical Research is responsible for providing clinical and medical expertise across all phases of clinical trials. Working in close partnership with the Clinical Research Administrator, this role ensures patient safety, protocol integrity, data quality, and compliance with regulatory and ethical standards. The role serves as a key liaison between the investigators and cross-functional teams to support the successful execution of clinical trials.
KEY RESPONSIBILITIES
Medical Oversight & Patient Safety
Serve as the primary medical contact for clinical trial sites and safety queries.
Conduct ongoing medical review of clinical trial data, including adverse events (AEs), serious adverse events (SAEs), and protocol deviations.
Ensure timely medical assessment and reporting of safety data to internal and external stakeholders.
Alongside the Clinical Research Administrator, ensure trials are conducted in accordance withICH-GCP, local regulations, and internal SOPs.
Support preparation and review of clinical and safety sections of regulatory documents (e.g., INDs, CTAs, CSRs).
Maintain awareness of current dermatologic clinical practice and evolving regulatory expectations related to dermatology studies.
Protocol Development & Scientific Leadership
Provide medical insight during protocol feasibility and site selection processes.
Review medical components of clinical study documents, including the Investigator Brochure (IB), Clinical Study Report (CSR), and Informed Consent Forms (ICFs).
Provide guidance on the use of clinical photography, lesion tracking, histopathology requirements, and biomarker collection (e.g., skin biopsies).
Review subject enrollment eligibility and diagnostic accuracy of dermatologic conditions.
Cross-functional Collaboration
Work closely with clinical operations, data management, and compliance teams
Participate in clinical trial team meetings and provide medical expertise throughout the trial lifecycle.
Support training of clinical site staff and internal teams on the medical and scientific aspects of the study.
Regulatory & Ethical Compliance
Ensure studies are conducted in accordance with ICH GCP, local regulations, and company SOPs.
Support regulatory filings, including IND/CTA submissions and responses to health authority queries.
Contribute to the development of safety narratives and clinical sections of regulatory documents.
KNOWLEDGE, SKILLS, AND ABILITIES
Knowledge of ADCS policies, including quality assurance policies and applicable government regulations and standards, and the ability to actively apply that knowledge in the performance of all job duties
Knowledge of electronic health record access-level privileges and responsibilities, and the ability to perform electronic health record job duties for this position within the parameters of the access level assigned
Ability to practice confidentiality and follow HIPAA regulations with patient information
Ability to practice professional ethics and use discretion concerning ADCS directives and proprietary information/trade secrets of the organization
Ability to recognize a problem and effectively problem-solve, using guidance from the provider and/or management when necessary
Knowledge of medical terminology and ability to use appropriately
Ability to manage time efficiently, prioritize, multi-task, and adapt to change
Ability to maintain high level of accuracy in all documentation and in the performance of all job duties
Ability to perform the essential job duties within the scope of education and training
Skilled in typing/keyboarding; skilled in using computers
PROFESSIONALISM
Project a professional manner and image, including proper workplace attire and grooming standards; exhibitprofessional conduct at all times
Adhere to ethical principles and core ADCS values; follow all ADCS policies
Treat all patients and staff with respect, compassion, and empathy, recognizing and respecting cultural diversity
Demonstrate initiative and responsibility for actions
Work as an effective team member
Maintain a strong record for attendance and punctuality in arriving at work
Enhance skills through continuing education
Education: MD, DO, or equivalent medical degree; board certification preferred.
Experience:
Minimum 3–5 years of clinical research experience
Prior experience as a clinical research physician strongly preferred.
LANGUAGE/COMMUNICATION REQUIREMENTS
Ability to read and interpret work-related documents such as reports, communications, safety rules, operating and maintenance instructions, and procedure manuals
Ability to write routine reports and correspondence
Ability to listen, speak, and interact effectively with all patients and co-workers, adapting communication for optimal understanding
Ability to practice professional telephone etiquette and techniques on all calls
MATHEMATICAL SKILLS
To the extent necessary for the performance of the job duties of a Medical Assistant – such as pharmacology-related job duties (mixing medications, Botox, lidocaine, etc.) – the ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
REASONING ABILITY
Ability to understand and follow instructions, both written and verbal. Must possess strong problem identification/resolution skills and be able to manage complications involving several variables.
WORK ENVIRONMENT AND CONDITIONS
Work is performed in a medical clinic and offices. Involves frequent telephone and in-person contact with patients, staff, vendors, providers, and management. Requires some flexibility in working hours. Requires the ability to work in a demanding environment and to effectively resolve conflicts as they arise. Occasional weekend work may be required. Occasional travel to clinical sites, investigator meetings, or conferences may be required.
PHYSICAL DEMANDS
Work requires sitting with prolonged periods of walking and standing. Tasks require grasping, fine finger and hand dexterity, and computer keyboarding and mouse usage. This position requires that the employee be able to push/pull, reach, bend, and kneel/crouch/squat. Occasional lifting up to 25 pounds. Normal vision required, with or without corrective lenses. Normal hearing is required.
