Sr Clinical Research Associate

Company Description

iProcess is a leading provider of biospecimen and clinical research services, supporting pharmaceutical, biotech, diagnostic, and academic clients worldwide. With a strong presence in India, US and a global partner network, we specialize in the ethical collection, processing, and delivery of high-quality human biospecimens—from fresh tissue and blood to FFPE and frozen samples—across diverse therapeutic areas.

Our experienced operations team ensures regulatory compliance, rapid turnaround, and tailored solutions that meet the unique requirements of each project. At iProcess, we are committed to advancing biomedical research by enabling access to ethically sourced, high-quality biospecimens and associated data.

Role Description

We are seeking an experienced and detail-oriented Senior Clinical Research Associate (CRA) to oversee biospecimen collection studies across multiple countries. In this role, you will ensure compliance with international regulations, maintain biospecimen integrity, and enforce adherence to study protocols. You will act as a key liaison between global clinical sites, biorepositories, laboratories, and internal teams, supporting high-quality data and sample collection.

Essential Function and Responsibility

• Serve as the primary point of contact for iProcess at specimen collection sites, ensuring smooth communication and accurate clinical data transfer.
• Facilitate Investigator and Sponsor Meetings, and actively participate in internal and external project meetings.
• Manage regulatory documentation for study initiation, monitoring, and evaluation, including obtaining necessary approvals.
• Draft Collection Protocols, Consent Forms, and Case Report Forms (CRFs).
• Independently conduct all types of monitoring visits (pre-study, initiation, interim, and close-out) for biospecimen collection studies.
• Ensure strict compliance with ICH-GCP, study protocols, and institutional/regulatory guidelines for biospecimen handling, storage, and shipment.
• Train and support site staff on biospecimen kits, labeling, documentation, and shipping requirements.
• Monitor chain-of-custody records, reconcile sample data, and resolve discrepancies promptly.
• Oversee the quality and integrity of biospecimens and ensure accurate data capture in tracking systems or EDC platforms.
• Collaborate with biorepositories, couriers, and laboratories to ensure timely specimen transport and tracking.
• Review site documentation for regulatory compliance and ensure Trial Master File (TMF) completeness.
• Provide mentorship and guidance to junior CRAs and site staff.
• Perform other responsibilities as assigned by the Clinical Research Manager or management team.
  

Qualifications

• 2–3 years of experience as a Clinical Research Associate (CRA), preferably with exposure to biospecimen collection.
• Bachelor’s degree in Life Sciences, Nursing, or a related field; Master’s degree or Clinical Research certification preferred.
• Strong understanding of clinical research processes, medical terminology, and biospecimen best practices (cold chain logistics, labeling standards, sample tracking).
• Proven ability to manage clinical trials or collection studies, including virtual management of study sites.
• Excellent written and verbal communication skills to engage with study teams, investigators, and partners.
• Demonstrated relationship-building skills; prior experience working with U.S. institutions and sites is an advantage.
• Highly organized, with the ability to manage multiple projects and shifting priorities.
• Independent problem-solving skills within complex clinical research environments.
• Collaborative mindset with the ability to mentor junior staff and work effectively in a matrix team structure.
• Thorough knowledge of GCP/ICH guidelines and relevant regulatory requirements.

Preferred Qualifications

• Prior experience in global biobanking initiatives, longitudinal cohort studies, or population-based biospecimen collection programs.
• Proven expertise in biospecimen logistics, including temperature-sensitive shipping and navigating customs requirements.
• Familiarity with CAP/CLIA guidelines and an understanding of pre-analytical variables affecting biospecimen quality.
• Candidates with prior U.S. work experience are strongly preferred.

Physical Qualifications

• Standard office duties with minimal physical effort.
• Extensive verbal and written communication skills, requiring clear speech and hearing.
• Ability to sit for extended periods.
• Flexibility to work with international regions based on operational needs.

Work Schedule

• Full-time hybrid role.
• Work hours:

Monday – Thursday: 6:00 PM to 3:00 AM IST

Friday: 3:30 PM to 12:30 AM IST

• Bangalore office attendance is required on Mondays and Fridays; remote work is permitted on other days.
• Schedule will adjust to align with U.S. Daylight Saving Time.