Offer summary

Qualifications:

Minimum 2 years of relevant experience in clinical research or related fields., Knowledge of clinical research methodology, industry regulations, and Good Clinical Practice guidelines., Proficiency in MS Office and business software applications., Ability to work independently and collaboratively in a team environment..

Key responsibilities:

Interpret and analyze clinical trial protocols to design study calendars and develop site budgets.

Create case report forms for clinical trials based on study protocols.

Utilize clinical trial management and electronic data capture software for designing and developing study materials.

Participate in team meetings and contribute to discussions on protocols and customer cases.

Job description

Company Information

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.

Company Culture

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.

Job Duties & Responsibilities

Understand and interpret clinical trial study protocols to design and develop calendars. Understand and interpret clinical trial agreements and sponsor budgets to develop site budgets for the protocol.

Design and develop case report forms for clinical trial study protocols

Develop a familiarity with Advarra’s Clinical Trial Management Software (CTMS) and Electronic Data Capture (EDC) software to utilize related functionalities in the design and development of calendars, budgets, financials and case report forms.

Work closely with reporting manager to complete daily/ weekly calendars, budgets, financials and/or case report forms design to meet with pre-determined quality criteria.

Understand and utilize internal case management software and other reporting software to ensure that daily/weekly work assignments are appropriately tracked and completed.

Actively participate in team meetings and contribute meaningfully to discussions related to specific customer cases and/or protocols.

Location

This role is open to candidates working remotely or hybrid in Bengaluru, India.

Basic Qualifications

2+ Years’ of relevant experience

Knowledge of clinical research methodology, industry regulations and Good Clinical Practice guidelines related to human research.

Expected to work independently, as well as in a team environment.

Good organizational and administrative abilities

Familiarity with MS Office and various business software

Preferred Qualifications

Clinical trial coordinator at site

Clinical data management

Pharmacovigilance

Records management

Physical and Mental Requirements

Sit or stand for extended periods of time at stationary workstation

Regularly carry, raise, and lower objects of up to 10 Lbs.

Learn and comprehend basic instructions

Focus and attention to tasks and responsibilities

Verbal communication; listening and understanding, responding, and speaking

Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by central, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment

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