Clinical Research Physician
A fast growing CRO is looking for a Clinical Research Physician to lead clinical trials at a clinical site in Baltimore, Maryland.
This role will suit an MD in clinical practice looking to get away from direct patient involvement and to move into clinical research.
Job duties:
Execute all appropriate Investigator responsibilities on assigned projects.
Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficient and compliant clinical operation of the unit.
Assist with the medical and clinical oversight of all aspects of function and work performed within the unit.
Assist with training and input on performance assessments for clinical operations personnel.
Work directly with clinical operations personnel in reviewing laboratory data, performing physical assessments, medical histories, and evaluation of inclusion/exclusion criteria for study participants.
Participate in the review and coding of adverse events and concomitant medications for accuracy and consistency.
Provides medical consultation as required or requested by the client/sponsor or the Baltimore EPCU staff.
Provides support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested.
Participate in on-call and general physician coverage schedule for the EPCU.
Establish working relationships with client representatives, promoting confidence and reliability regarding the EPCUs operations.
.
Liaise with sponsors on study conduct and study progression as requested.
Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and if noted, follow-up as appropriate with the clinical team, project team sponsor, investigator and regulatory agencies.
Participates in the review of individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness.
Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis summarizing adverse experiences as required by the FDA or the sponsor as needed.
Ensures that all established timelines relating to areas of responsibility and assigned projects are met.
Ensures that the quality standard of clinical work product is met.
Requirements:
Clinical practice experience and board certification in General Medicine preferred.
Clinical or pharmaceutical research experience is desirable but not required.
Unrestricted license to practice in Maryland required or ability to obtain.
MD or DO required This is an on site role but flexible hours and working from home may be offered.
You will start in a Clinical Research Physician role but career progression is offered.
For more information on this exciting and well funded growing biotech please forward an up to date resume to @rbwconsulting.
com.
Estimated Salary: $20 to $28 per hour based on qualifications.
This role will suit an MD in clinical practice looking to get away from direct patient involvement and to move into clinical research.
Job duties:
Execute all appropriate Investigator responsibilities on assigned projects.
Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure the efficient and compliant clinical operation of the unit.
Assist with the medical and clinical oversight of all aspects of function and work performed within the unit.
Assist with training and input on performance assessments for clinical operations personnel.
Work directly with clinical operations personnel in reviewing laboratory data, performing physical assessments, medical histories, and evaluation of inclusion/exclusion criteria for study participants.
Participate in the review and coding of adverse events and concomitant medications for accuracy and consistency.
Provides medical consultation as required or requested by the client/sponsor or the Baltimore EPCU staff.
Provides support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested.
Participate in on-call and general physician coverage schedule for the EPCU.
Establish working relationships with client representatives, promoting confidence and reliability regarding the EPCUs operations.
.
Liaise with sponsors on study conduct and study progression as requested.
Participates in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and if noted, follow-up as appropriate with the clinical team, project team sponsor, investigator and regulatory agencies.
Participates in the review of individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness.
Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis summarizing adverse experiences as required by the FDA or the sponsor as needed.
Ensures that all established timelines relating to areas of responsibility and assigned projects are met.
Ensures that the quality standard of clinical work product is met.
Requirements:
Clinical practice experience and board certification in General Medicine preferred.
Clinical or pharmaceutical research experience is desirable but not required.
Unrestricted license to practice in Maryland required or ability to obtain.
MD or DO required This is an on site role but flexible hours and working from home may be offered.
You will start in a Clinical Research Physician role but career progression is offered.
For more information on this exciting and well funded growing biotech please forward an up to date resume to @rbwconsulting.
com.
Estimated Salary: $20 to $28 per hour based on qualifications.
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