Clinicalinvestigator,clinop-arpl-bc Ar - Bengaluru, India - Apotex Research Private Limited
Description
About Apotex Inc.
Job Summary:
Handle and administer the BE studies or clinical trial in Bioequivalence center, India also managing the screening and in study assessment and medical care of clinical volunteers.
Responsibilities:
- Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center's Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
- Participates as Clinical investigator/principal investigator for assigned BE studies or Clinical trials.
- Interviews potential volunteers
- Assesses the previous history of the Volunteers, Performs physical examination, including Medical history of the potential volunteers
- Providing inputs or Review of Protocol ,ICF and other study related documents before the start of the study and providing feasibility for conducting studies on critical drugs
- Assesses the previous Medical history of the Volunteer and Performs physical examination of the potential volunteers
- Reviews screening results and assesses volunteer suitability for entry into studies
- Conducts screening of potential study volunteers
- Responsible for meal plan in collation with dietician
- Judgment of Lab reports
- Completion of study participation summary
- Directly supervises and delegates responsibility to the clinic staff to execute duties as per the SOP and protocol requirements.
- Oversees and assists in the administration of test articles
- Reviews applicable clinical reports as required
- Handling of medical emergencies and approves the use of onsite necessary emergency medical equipment Works and/or liaises with external medical services as required for appropriate adverse event followup
- Assists with training of medical personnel
- Ensures payment to volunteers/Subjects as per compensation policy
- Assists in the creation, development and revision of the Bioequivalence Center's Clinical Operations Department Standard Operating Procedures.
- Performs delegated acts as per delegation statement
- Providing conceptual inputs to the Management in line with company business objectives
- Ensures that appropriate corrections were taken for QA observations and followed.
- Executes other duties related to a study as may be assigned by the respective Principal investigator as training and experience allow.
- Executes other duties as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
Job Requirements:
- M.B.B.S/M.D
- Current experience in patient care
- Familiarity with TPD, FDA ICH and EU Guidance's with respect to the conduct of bioequivalence studies or clinical trials would be an asset
- Understanding of the Statement of Investigator and Qualified Investigator Undertaking
- 34 years experience Preferable
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
More jobs from Apotex Research Private Limited
-
Executive, Mts Process Validation
Mumbai, Maharashtra, India - 3 weeks ago
-
Junior Officer-apipl-qct Ap
Bengaluru, India - 1 week ago
-
Executive, QA Validation
Bengaluru, Karnataka, India - 2 weeks ago
-
Executive- Regulatory Affairs PLCm
Mumbai, Maharashtra, India - 2 weeks ago
-
Executive, Gpv Safety Operations, Pv
Mumbai, Maharashtra, India - 3 weeks ago
-
Executive, Regulatory Affairs PLCm
Mumbai, Maharashtra, India - 4 days ago