Armauer Hansen Research Institute (AHRI) in collaboration with St Paul Hospital Millennium Medical College (SPHMMC) and Children Hospital of Philadelphia (CHOP) is planning to conduct a clinical trial entitled “Efficacy of probiotic supplementation in preterm and small for gestational age infants. A WHO Sponsored multi-center, individually-randomized trial (Probiotics in preterm and small for gestational infants, PROPS trial) ". The project is founded by Gates Foundation and Coordinated by Johns Hopkins University.  We are looking for study pharmacists and study laboratory technologist, for effective implementation of the trial as listed below. The recruited study staff will work in collaboration with the project PIs, study coordinators and field supervisors; work package leads and the project staff at AHRI and SPHMMC as well as perform field activities.

Duty location: Armauer Hansen Research Institute and Gandhi Memorial Hospital
Position type: Full-time, one year with a possibility of renewable depending on performance

1. Project Coordinator (Study Pharmacists)

Position Summary
Study Pharmacists will be the custodians of the investigational product (IP) and central to ensuring the integrity of the trial's blinding and randomization. They will be responsible for IP management, randomization, dispensing, accountability, and ensuring compliance with Good Clinical Practice (GCP) and regulatory standards.

Duties and Responsibilities

1. Investigational Product (IP) Management and Storage

• Receive, store, and manage all trial supplies in a secure, dedicated, and temperature-controlled environment as per the protocol.

• Maintain accurate inventory logs and monitor storage conditions.

1.  Randomization and Dispensing

• Execute the computer-generated randomization list to assign enrolled infants to their study groups.

• Dispense pre-packaged, blinded probiotic/placebo sachets and other study supplies to the Study Nurses according to the randomization code and trial protocol.

• Ensure strict maintenance of the blinding throughout the trial.

1.  Accountability and Reconciliation

• Maintain meticulous records of IP dispensing, returns and destruction.

• Conduct regular IP accountability checks and reconcile quantities used against enrollment numbers.

• Prepare for and assist with IP accountability during monitor visits and audits.

1.  Quality and Compliance

• Ensure all IP-related activities comply with GCP, SOPs, and regulatory requirements.

• Verify the integrity and blinding of the IP throughout the trial.

• Report any IP deviations (e.g., temperature excursions, dispensing errors) to the study coordinator immediately.

• Monitor the pharmacy warehouse, dispensing areas and refrigerators 24/7 and immediately report any environmental deviations to the supervisor, taking corrective action as indicated by the quality assurance standard operating procedure.

1. Support and Collaboration

• Provide training and support to Study Nurses on the proper handling, administration, and accountability of the IP.

• Collaborate with the study coordinator and monitor to resolve any IP-related issues.

Job Requirements

Required Qualification

• B.Pharm degree with an active license to practice.

• ˃2 years’ experience in a hospital pharmacy setting; experience in a neonatal/pediatric unit is highly desirable.

• Clinical research or trial experience, particularly in IP management, is preferred.

• In-depth knowledge of GCP, pharmacy laws, and ethical guidelines related to clinical trials.

• Meticulous attention to detail and strong organizational skills for accurate record-keeping.

• Ability to work effectively within a multidisciplinary research team.

Number of positions: 02

Salary: Competitive and as per AHRI’s salary scale

Duty location: Armauer Hansen Research Institute (one position) and Gandhi Memorial Hospital (one position) with frequent travel to different study sites.

How To Apply

How to Apply: application letter (detailing your motivation and suitability), CV (maximum of three pages with clear indication of your educational background and experience) and copies of your documents and certificates as one PDF file Submit you’re through THIS LINK