Opening for Clinical Research Physician @ Apotex Inc
Job Summary
Assists the Manager Clinical Operations in smooth and timely conduct of clinical studies at Clinical Facility by performing coordination activities and providing medical related services.
Job Profile
Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centres Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
Responsible for the screening and in-study assessment and medical care of all potential clinical volunteers/subjects.
Reviews study information prior to start of screening
Conducts screening of potential study volunteers
a) Interviews potential volunteers
b) Performs physical examination, including Medical history, of the potential volunteers
c) Assesses the previous history of the clinical candidate.
Reviews screening results and assesses volunteer suitability for entrance into studies
Provides medical counselling to volunteers with abnormal screening results
Participates as responsible Clinician for selected studies including
Reviews clinical protocol and ICF prior to commencement of study:
Reviews subject eligibility to verify protocol requirements
Confirms subject comprehension of study activities and ensures Informed consent is given prior to entry into study.
Oversees and assists in the administration of test articles
Assesses subjects adverse events and provides appropriate medical follow up
Withdraws subjects as necessary to protect subject safety
Reviews subject monitoring and safety data during the conduct of the study
Performs end of confinement assessments and discharges subjects from the study site
Works and/or liaises with external medical services as required for appropriate adverse event follow-up
Reviews applicable clinical reports as required
Supervises the management of medical emergencies and approves the use of on-site necessary emergency medical equipment
Assists with training of medical personnel
Responsible for meal plan in collation with dietician
Assists in the creation, development and revision of the Bioequivalence Centres Clinical Operations Department Standard Operating Procedures.
Performs delegated acts as per delegation statement
Supervises the activities of Nurses and Duty Medical Officers for rendering medical services to the subject at the Clinical Facility.
Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
Desired Profile
Qualification
M.B.B.S
Years of Experience
Minimum 2 years of experience in BA/BE setup
Current experience in patient care
Familiarity with TPD, FDA and ICH Guidances with respect to the conduct of bioequivalence studies or clinical trials would be an asset
Understanding of the Statement of Investigator and Qualified investigator
Job Description
Responsible for the screening and in-study assessment and medical care of all potential clinical volunteers/subjects.
Reviews study information prior to start of screening
Conducts screening of potential study volunteers
a)Interviews potential volunteers
b)Performs physical examination, including Medical history, of the potential volunteers
c)Assesses the previous history of the clinical candidate.
Reviews screening results and assesses volunteer suitability for entrance into studies
Provides medical counselling to volunteers with abnormal screening results
Participates as responsible Clinician for selected studies including
Reviews clinical protocol and ICF prior to commencement of study:
Reviews subject eligibility to verify protocol requirements
Confirms subject comprehension of study activities and ensures Informed consent is given prior to entry into study.
Oversees and assists in the administration of test articles
Assesses subjects adverse events and provides appropriate medical follow up.
Withdraws subjects as necessary to protect subject safety
Reviews subject monitoring and safety data during the conduct of the study
Performs end of confinement assessments and discharges subjects from the study site.
Works and/or liaises with external medical services as required for appropriate adverse event follow-up.
Reviews applicable clinical reports as required.
Supervises the management of medical emergencies and approves the use of on-site necessary emergency medical equipment
Assists with training of medical personnel.
Responsible for meal plan in collation with dietician
Assists in the creation, development and revision of the Bioequivalence Centres Clinical Operations Department Standard Operating Procedures.
Performs delegated acts as per delegation statement.
Supervises the activities of Nurses and Duty Medical Officers for rendering medical services to the subject at the Clinical Facility.
Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
Salary: Best In the Industry
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Medical Officer
Role: Medical Officer
Keyskills: Clinical Operations, Clinical Research, Standard Operating Procedures, Clinical Research Physician, Clinical Data Management.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Medical Officer
Role: Medical Officer
Keyskills: Clinical Research Physician,clinical research associate phys ,clinical trial physician ,pharmacovigilance physician ,doctors physician
Click here to apply
Job Summary
Assists the Manager Clinical Operations in smooth and timely conduct of clinical studies at Clinical Facility by performing coordination activities and providing medical related services.
Job Profile
Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centres Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
Responsible for the screening and in-study assessment and medical care of all potential clinical volunteers/subjects.
Reviews study information prior to start of screening
Conducts screening of potential study volunteers
a) Interviews potential volunteers
b) Performs physical examination, including Medical history, of the potential volunteers
c) Assesses the previous history of the clinical candidate.
Reviews screening results and assesses volunteer suitability for entrance into studies
Provides medical counselling to volunteers with abnormal screening results
Participates as responsible Clinician for selected studies including
Reviews clinical protocol and ICF prior to commencement of study:
Reviews subject eligibility to verify protocol requirements
Confirms subject comprehension of study activities and ensures Informed consent is given prior to entry into study.
Oversees and assists in the administration of test articles
Assesses subjects adverse events and provides appropriate medical follow up
Withdraws subjects as necessary to protect subject safety
Reviews subject monitoring and safety data during the conduct of the study
Performs end of confinement assessments and discharges subjects from the study site
Works and/or liaises with external medical services as required for appropriate adverse event follow-up
Reviews applicable clinical reports as required
Supervises the management of medical emergencies and approves the use of on-site necessary emergency medical equipment
Assists with training of medical personnel
Responsible for meal plan in collation with dietician
Assists in the creation, development and revision of the Bioequivalence Centres Clinical Operations Department Standard Operating Procedures.
Performs delegated acts as per delegation statement
Supervises the activities of Nurses and Duty Medical Officers for rendering medical services to the subject at the Clinical Facility.
Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
Desired Profile
Qualification
M.B.B.S
Years of Experience
Minimum 2 years of experience in BA/BE setup
Current experience in patient care
Familiarity with TPD, FDA and ICH Guidances with respect to the conduct of bioequivalence studies or clinical trials would be an asset
Understanding of the Statement of Investigator and Qualified investigator
Job Description
Responsible for the screening and in-study assessment and medical care of all potential clinical volunteers/subjects.
Reviews study information prior to start of screening
Conducts screening of potential study volunteers
a)Interviews potential volunteers
b)Performs physical examination, including Medical history, of the potential volunteers
c)Assesses the previous history of the clinical candidate.
Reviews screening results and assesses volunteer suitability for entrance into studies
Provides medical counselling to volunteers with abnormal screening results
Participates as responsible Clinician for selected studies including
Reviews clinical protocol and ICF prior to commencement of study:
Reviews subject eligibility to verify protocol requirements
Confirms subject comprehension of study activities and ensures Informed consent is given prior to entry into study.
Oversees and assists in the administration of test articles
Assesses subjects adverse events and provides appropriate medical follow up.
Withdraws subjects as necessary to protect subject safety
Reviews subject monitoring and safety data during the conduct of the study
Performs end of confinement assessments and discharges subjects from the study site.
Works and/or liaises with external medical services as required for appropriate adverse event follow-up.
Reviews applicable clinical reports as required.
Supervises the management of medical emergencies and approves the use of on-site necessary emergency medical equipment
Assists with training of medical personnel.
Responsible for meal plan in collation with dietician
Assists in the creation, development and revision of the Bioequivalence Centres Clinical Operations Department Standard Operating Procedures.
Performs delegated acts as per delegation statement.
Supervises the activities of Nurses and Duty Medical Officers for rendering medical services to the subject at the Clinical Facility.
Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
Salary: Best In the Industry
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Medical Officer
Role: Medical Officer
Keyskills: Clinical Operations, Clinical Research, Standard Operating Procedures, Clinical Research Physician, Clinical Data Management.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Medical Officer
Role: Medical Officer
Keyskills: Clinical Research Physician,clinical research associate phys ,clinical trial physician ,pharmacovigilance physician ,doctors physician
Click here to apply
0 comments:
Post a Comment