Clinicalinvestigator,clinop-arpl-bc Ar

6 months ago

Bengaluru, India Apotex Research Private Limited Full time

**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 on-site necessary emergency medical equipment Works and/or liaises with external medical services as required for appropriate adverse event follow-up
- 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
- 3-4 years experience Preferable

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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