Clinical Research Coordinator

2 weeks ago

Delhi, India Biosite Research Private Limited Full time

Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities.
- Develop accurate source materials and ensures compliance from site staff.
- Provide accurate and timely data collection, documentation, entry, and reporting in both sponsor and databases.
- Ensure appropriate credentialing and training of the entire team.
- Supports the regulatory staff in the maintenance of regulatory documents in accordance with SOP and applicable regulations.
- Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol.
- Communicate and collaborate specific study requirements to the research team, including internal and external parties, sponsor, monitors, PI, and study participants.
- Ensure compliance with research protocols by providing ongoing quality control audits, including maintaining ongoing investigational drug accountability.
- Disburse investigational drug and provides patient teaching regarding administration, as necessary. Communicate and collaborate with study team, including internal and external parties, sponsors, PI, and study participants.
- Taking the responsibility of Patient Recruitment.
- Knowledge of medical terminology, clinical medicine, clinical trials and GCP concepts
- Detail-oriented and meticulous in all aspects of work
- Strong follow-through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative.
- Must have professional demeanour and strong communication skills with the public as well as physicians/researchers.
- Ability to work well independently as well as in team environment.
- Strong interpersonal, customer service, and multi-tasking skills are critical.
- Should be Proficient in Microsoft Office Word and Excel, electronic health systems and databases used in research environment, or have a willingness to learn and demonstrate proficiency within six months of hire.
- Ability to be flexible, organized, detail-oriented and tenacious in follow-through.
- Possess the ability to work well under pressure, multi-task and manage deadlines.
- Taking full responsibility of completion of Recruitment of Patients in the given Study.
- Help investigator in recruitment of patients and able to ensure patient visits according to study protocol and maintaining Compliance, recording of AEs and SAEs according to GCP n regulatory guidelines, communication to Site Ethics Committee, attending EC meetings etc within the time frame.
- Attend all Monitoring visits, Audits, and resolve the queries according to study requirement. Maintaining ISF and conducting other study related activities as assigned by Investigator.

**Job Types**: Full-time, Regular / Permanent

**Salary**: From ₹22,000.00 per month

Schedule:

- Fixed shift

**Experience**:

- total work: 1 year (preferred)

Application Deadline: 15/07/2023
Expected Start Date: 03/07/2023

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