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Clinical Research Associate

2 months ago

Bhubaneswar, India Larkai Healthcare Full time


About Us

We are a team of enthusiastic minds constantly researching and developing technologies to promote healthcare.

We envision to be a complete health data company using AI based predictions backed by human research for detecting diseases, thereby helping people across the globe to live healthy lives by being aware of their health conditions on time. With an extensive research, data analysis and consistent up building, Larkai has successfully built clinically approved devices. We’ve tested over 300,000 people across the globe, and concluded a 99.22% data accuracy rate.

We are looking for an organized, flexible clinical research associate to oversee clinical trials. The clinical research associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigation Product (IP) and trial materials. The clinical research associate will manage multiple aspects of the subjects' welfare.


Job Title: Clinical Research Associate

Location: Bhubaneswar, India

Duration: Full Time

Experience : 0-2 years



Key Responsibilities:

· Creating and writing trial protocols, and presenting these to the steering committee.

· Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.

· Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.

· Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.

· Ordering, tracking, and managing IP and trial materials.

· Overseeing and documenting IP dispensing inventory, and reconciliation.

· Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.

· Conducting regular site visits, coordinating project meetings, and writing visit reports.

· Implementing action plans for sites not meeting expectations.

· Liaising with regulatory authorities.

· Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.

· Other tasks and responsibilities as needed.


Qualifications:

•  Bachelor’s or Master’s degree in biological science or a related field.

• Ability to work independently and as part of a team in a fast-paced environment

• Strong analytical skills and attention to detail


Skills:

· Ability to conduct trials and understand loopholes.

· Ability to manage and prioritize workload effectively.

· Available to travel extensively and on short notice

· Ability to manage travel schedules.

. Must be proficient in Odia language (Verbal and written)