Sr Clinical Research Associate - Bengaluru, India - iProcess Global Research Inc

Description

Company Overview:

iProcess is a leader in biospecimen collection studies, providing key contributions to the advancement of medical research. Our speciality in the procurement and handling of quality biospecimens underpins crucial developments in medical diagnostics and therapies. For more information about our dedicated approach to medical research, visit

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Job Description:

iProcess is searching for a skilled Clinical Research Associate (CRA) to take charge of various aspects of biospecimen collection studies. This role involves independent management of specimen collection, accurate data management, regulatory compliance, and a commitment to the advancement of medical research.

Essential Functions and Responsibilities:

• Act as the primary point of contact for iProcess at specimen collection sites, ensuring effective communication and clinical data transfer.
• Facilitate Investigator and Sponsor Meetings, as well as attend other important internal and external meetings.
• Handle regulatory documentation for the initiation, monitoring, and evaluation of collection studies, including obtaining necessary approvals.
• Create Collection Protocols, Consent Forms, and Case Report Forms.
• Oversee study initiation, including monitoring and study close-out activities, ensuring adherence to protocols.

Qualifications:

• At least 2-3 years of experience as a Clinical Research Associate, with a general focus on clinical trials. Experience in biospecimen collection is a plus but not mandatory.
• A Bachelor's degree in Life Sciences, Nursing, or a related field; a Master's degree or certification in Clinical Research is preferred.
• In-depth knowledge of clinical research processes and medical terminology.
• Proven ability to oversee clinical trials or collection studies, with virtual management capabilities.
• Excellent communication skills for interaction with study personnel and partners.
• Strong relationship-building skills, with prior experience working with U.S. institutions and sites being beneficial.
• Superior organizational skills, capable of managing multiple projects and priorities.
• Independent problem-solving abilities within clinical research environments.
• Readiness to work collaboratively, mentor junior staff, and adapt to a matrix team structure.
• A solid understanding of GCP/ICH guidelines relevant to clinical research.

Physical Requirements:

• Standard office duties with minimal physical effort.
• Extensive verbal and written communication, necessitating clear speech and hearing.
• Regular use of the keyboard, requiring repetitive finger movements.
• Frequent sitting for extended periods.
• Willingness to work with different international regions as required by operational needs.

Work Schedule:

Full-time, hybrid position with work hours from 6:00 PM to 3:00 AM IST Monday through Thursday, and 3:30 PM to 12:30 AM IST on Fridays. Bangalore office attendance is required on Mondays and Fridays, with the flexibility of remote work on other days. The schedule is subject to changes aligned with U.S. Daylight Saving Time.