Clinical Research Coordinator

JOB DESCRIPTION

JOB SUMMARY / ROLE:

The Clinical Research Coordinator will plan, direct, or coordinate INPHOG clinical research projects, and will evaluate and analyse clinical data.

JOB RESPONSIBILITIES: 

• To facilitate and coordinate the all daily INPHOG clinical research trial activities for sponsored & academic studies, for assigned projects. 
• To review and comprehend each assigned INPHOG protocol including study proceedings and timelines.
• Interviewing families/patients and collecting and entering data at one or more hospitals which are participating in the INPHOG study. 
• Complete case report forms. Extracts data from patient file (Source documents) in a timely manner.
• Complete and accurate entry of all data collected into Data Entry Forms  
• Developing relationships with key individuals in assigned hospital to ensure successful implementation of study including; doctors from all departments and other social support team members, hospital administration, etc. 
• Work under close supervision of the primary delegate or reporting manager
• Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure protocols are followed and that there is timely documentation and submission of study data.
• To Complete Feasibility, To Conduct Site Selection Visit, To Maintain trial related Document, To Prepare Protocol, Dossier Submissions & Presentation for EC
• Coordinating with the sponsor, PI, legal & finance in order to finalise the CTA & Study Budgets.

• Subject Screening Activities, Maintain Source documentation, dispense IP and manage lab procedures.
• Conduct reminder calls, prepare for subject study visit, manage study subject’s reimbursements, AE & SAE reporting, Source Document Maintenance,
• Investigator Site File management, IP accountability & CRF Completion, completion of all study logs.               
• Working with the sponsor monitors (CRA’s) during their monitoring visits.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required.
• Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer.
• Promotes the ethical conduct of research by reporting in good faith any suspicions of misconduct in research.
• Any other activities deemed necessary by the primary delegate or reporting manager for the efficient conduct of the trial. 

COMPETENCIES/ SKILL SET:

• Excellent written and oral communication skills in English and regional language
• Proficient in use of computers (MS Office) and internet applications
• Counselling and mentorship skills
• Analytical and documentation skills
• Accepts and ensures rigor in program implementation
• Knowledge of biological and medical terminology.
• Understanding of the principles of administration and management.
• Prolonged periods of sitting at a desk and working on a computer.
• Understanding of research database 

Apply at hr@inphog.org