Job Description
Contact: Alexandra Spink -
No 3rd party candidates
This role is 100% on site in Miramar FL.
Position Description
The Study Physician is responsible for ensuring the medical safety eligibility and ongoing clinical oversight of study participants in accordance with the protocol regulatory requirements and Good Clinical Practice (GCP). This role involves performing clinical assessments reviewing study data managing adverse events and collaborating closely with study staff and sponsors to ensure high-quality clinical trial conduct.
Key Responsibilities
- Conduct screening evaluations of healthy volunteers including routine physical examinations ECG interpretation laboratory review and eligibility assessments.
- Review screening documentation and approve subjects for study admission.
- Review admission documentation and approve subjects for study randomization.
- Perform physical examinations as part of screening and during active study participation.
- Interpret ECGs within sponsor-defined timelines.
- Monitor the ongoing safety and well-being of study participants throughout the trial.
- Identify assess and medically manage adverse events as appropriate.
- Ensure accurate documentation and timely reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Review and evaluate clinical study data including interpretation of out-of-range laboratory or diagnostic results and determine clinical significance.
- Document all clinical findings in subject-specific source documentation in accordance with study requirements.
- Provide on-site medical supervision during investigational product dosing as required.
- Delegate study responsibilities appropriately to trained study staff while maintaining oversight.
- Ensure all study activities are conducted in compliance with IRB-approved protocols.
- Maintain working knowledge of GCP/ICH guidelines clinic SOPs QA/QC procedures and regulatory documentation including the Investigator Form FDA 1572.
- Review the Investigators Brochure prior to performing study procedures.
- Communicate with sponsors monitors and auditors as required during study conduct.
- Participate in on-call coverage as needed to ensure adequate medical oversight.
- Provide medical coverage for the Clinic Principal Investigator when necessary.
- Work collaboratively within a multidisciplinary team-based research environment.
Core Qualifications
- MD with board certification in Internal Medicine (ABIM certified and verified); subspecialty training is acceptable.
- Active unrestricted Florida medical license.
- Clean DEA registration.
- Minimum of one year of clinical practice experience following completion of residency or fellowship training (hospital- or clinic-based practice acceptable).
- Strong understanding of clinical trial conduct patient safety monitoring and regulatory compliance.
Schedule: Variable shifts (typically 8 hours) including evenings and weekends as needed scheduled in advance based on clinic study requirements.
Required Experience:
IC
Job DescriptionContact: Alexandra Spink -No 3rd party candidatesThis role is 100% on site in Miramar FL.Position DescriptionThe Study Physician is responsible for ensuring the medical safety eligibility and ongoing clinical oversight of study participants in accordance with the protocol regulatory r...
Job Description
Contact: Alexandra Spink -
No 3rd party candidates
This role is 100% on site in Miramar FL.
Position Description
The Study Physician is responsible for ensuring the medical safety eligibility and ongoing clinical oversight of study participants in accordance with the protocol regulatory requirements and Good Clinical Practice (GCP). This role involves performing clinical assessments reviewing study data managing adverse events and collaborating closely with study staff and sponsors to ensure high-quality clinical trial conduct.
Key Responsibilities
- Conduct screening evaluations of healthy volunteers including routine physical examinations ECG interpretation laboratory review and eligibility assessments.
- Review screening documentation and approve subjects for study admission.
- Review admission documentation and approve subjects for study randomization.
- Perform physical examinations as part of screening and during active study participation.
- Interpret ECGs within sponsor-defined timelines.
- Monitor the ongoing safety and well-being of study participants throughout the trial.
- Identify assess and medically manage adverse events as appropriate.
- Ensure accurate documentation and timely reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs).
- Review and evaluate clinical study data including interpretation of out-of-range laboratory or diagnostic results and determine clinical significance.
- Document all clinical findings in subject-specific source documentation in accordance with study requirements.
- Provide on-site medical supervision during investigational product dosing as required.
- Delegate study responsibilities appropriately to trained study staff while maintaining oversight.
- Ensure all study activities are conducted in compliance with IRB-approved protocols.
- Maintain working knowledge of GCP/ICH guidelines clinic SOPs QA/QC procedures and regulatory documentation including the Investigator Form FDA 1572.
- Review the Investigators Brochure prior to performing study procedures.
- Communicate with sponsors monitors and auditors as required during study conduct.
- Participate in on-call coverage as needed to ensure adequate medical oversight.
- Provide medical coverage for the Clinic Principal Investigator when necessary.
- Work collaboratively within a multidisciplinary team-based research environment.
Core Qualifications
- MD with board certification in Internal Medicine (ABIM certified and verified); subspecialty training is acceptable.
- Active unrestricted Florida medical license.
- Clean DEA registration.
- Minimum of one year of clinical practice experience following completion of residency or fellowship training (hospital- or clinic-based practice acceptable).
- Strong understanding of clinical trial conduct patient safety monitoring and regulatory compliance.
Schedule: Variable shifts (typically 8 hours) including evenings and weekends as needed scheduled in advance based on clinic study requirements.
Required Experience:
IC
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