Principal Investigator (PI), Clinical Investigator (CI) and / or Centre-in-Charge

Span of Control: Lead the Design, Execution and Reporting of BA/BE research projects, and coordinate with Sponsors, Government Agencies, and Internal stakeholders

Post Qualification Experience: 10-15 years overall, with at least 5 years in Bioavailability / Bioequivalence (BA/BE) Research

Designation: Principal / Clinical Investigator

Qualification: Degree in Medicine, MBBS, M.D. (any specialisation)

Location: Thane Belapur Road, Navi Mumbai

Reporting to: Centre Head, VP of Clinics

JOB SUMMARY

The Principal Investigator will be responsible to conduct objective research that generates independent, high quality, and reproducible results. He will be responsible for the management and integrity of the design, execution, and reporting of the research project and for managing, monitoring, and ensuring the integrity of any collaborative relationships.

Additionally, the Principal Investigator will be responsible for the direction and oversight of compliance, financial, personnel, and other related aspects of the research project. He will also coordinate with Sponsor, Government Agencies Department and internal stakeholders to assure research is conducted in accordance with government regulations, Regulatory bodies (W.H.O, ANVISA, USFDA etc.) and sponsoring companies' policies and procedures.

JOB RESPONSIBILITIES

The incumbent will primarily be in charge of:

General Administration

- Coordinate with all Operating Managers to help ensure that sponsored research and related activities are in accordance with regulations and sponsoring companys policies and procedures.




- Administer and oversee research and all related activities.
- Assure that all key personnel involved in sponsored program administration have met training requirements in accordance with regulations and sponsoring agency policies and procedures.
- Support and endorse cooperation with compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office.
- Prepare Scientific Proposals
- Coordinate with department managers to obtain appropriate internal approvals and assure that proposals meet regulations and sponsoring companys policies and procedures prior to submitting proposal to sponsoring agency.
- Prepare short term and long-term plans to maximise the business potential. Prepare AOP and action plan along with resource requirements to achieve the AOP.

Propose Budgets

- Make key budgetary decisions and verify that appropriate budgets and cost projections are prepared to deliver the proposed project scope.
- Coordinate with department managers to prepare categorized budget and justification and confirm accuracy and completeness of budgeted costs.
- Oversee the conduct of research in accordance with regulations and sponsor agency policies and procedures.




- Oversee the research team to help ensure ethical conduct in all aspects of the research process including but not limited to the treatment of human and animal subjects, conflicts of interest, data acquisition, management, sharing and ownership, publication practices, responsible authorship, and cooperative research and reporting.
- Promote the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Accutest’s Research Integrity Policy Facilities and Administrative Cost Rate
- Identify program type to allow determination of correct facilities and administrative (F&A;) cost rate. Volunteer Selection etc.
- Coordinate with all internal functions to verify that the correct F&A; cost rate is applied to sponsored project budgets.

Space Management

- Use allocated space appropriately and efficiently and reports correct use of space to the management.
- Equipment Management
- Obtain, maintain, and safeguard equipment used to conduct research in accordance with government regulations and sponsoring agency policies and procedures.

Reporting

- Comply with technical, progress, and compliance reporting requirements in accordance with government regulations and sponsoring agency policies and procedures.

Project Closeout

- Submit accurate and timely closeout documents to applicable agencies, government entities, and the sponsoring agencies in accordance with the scope of the studies.

CANDIDATE PROFILE

- Degree in Medicine, MBBS, M.D. (any specialisation)
- 10-15 years overall, with at least 5 years in Bioavailability / Bioequivalence (BA/BE) Research

📌 Principal Investigator - Clinical Trials || CRO (Navi Mumbai)
🏢 Important Group
📍 Navi Mumbai