Clinical Research Associate null

About IQVIA

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. They believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help their customers create a healthier world. It has a network of more than 88,000 employees in more than 100 countries and a market capitalization of $49 Billion as of August 2021. The mission is to enable and promote a culture of wellness, safety, innovation, environmental responsibility and ethical business practice.

Your role

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Work with sites to adapt, drive and track subject recruitment plans in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support the start-up phase.
• Ensure copies/originals (as required) of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting the development of the project subject recruitment plan on a per-site basis.
• If applicable, may be accountable for site financial management according to an executed clinical trial agreement and retrieve invoices according to local requirements.

Training, development & rotation

IQVIA is committed to empowering employees to do their best work – and to do your best work you need to be constantly learning, growing, and becoming a better version of yourself. They give opportunities to use your expertise through your on-the-job experiences. It provides various opportunities for its employees to improve and grow while working for the company’s mission. The company is committed to offering opportunities to acquire new skills and strengthen its readiness to advance into new roles.

Salary & benefits 

The average annual salary for this role is around INR 3.7 Lakhs (Source: Glassdoor)

The company takes care of you and your loved ones and will support you with a competitive and comprehensive benefits package. Below are some highlights:

• Medical Insurance
• Disability insurance
• Pension Plan
• Stock Options or Equity
• Maternity & Paternity Leave
• Vacation & Paid Time Off
• Job Training & Tuition

Work-life balance

Work-Life balance is rated as 3.7/5.0 (Source: Glassdoor). Work days are usually from Monday to Friday. They have flexible work timings. They constantly provide opportunities for their employees to develop and upskill themselves. A place to learn and gain more skills as the company allows employees to explore new marketing techniques.

Culture & vibe

The culture at IQVIA is fun, hard work, perseverance and teamwork. The company provides an environment where people can reach their full potential. Employees are encouraged to take an active role in their professional growth and personal development.

About You

Here’s what they are looking for with this role:

Qualifications

• Bachelor's Degree Degree in a scientific discipline or health care preferred.
• An equivalent combination of education, training and experience may be accepted in lieu of a degree.
• Some organizations require completion of a CRA training programs or prior monitoring experience.
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in-company training.
• Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Written and verbal communication skills including good command of the English language.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

How to apply

To apply for this role, simply click the "Apply on employer site" button on this page to submit your application directly with IQVIA.