Sr Clinical Research Associate

In this role at iProcess, you will be responsible for overseeing biospecimen collection studies across multiple countries. Your key responsibilities will include: - Serving as the primary point of contact for iProcess at specimen collection sites to ensure smooth communication and accurate clinical data transfer. - Facilitating Investigator and Sponsor Meetings, and actively participating in internal and external project meetings. - Managing regulatory documentation for study initiation, monitoring, and evaluation, including obtaining necessary approvals. - Drafting Collection Protocols, Consent Forms, and Case Report Forms (CRFs). - Independently conducting all types of monitoring visits (pre-study, initiation, interim, and close-out) for biospecimen collection studies. - Ensuring strict compliance with ICH-GCP, study protocols, and institutional/regulatory guidelines for biospecimen handling, storage, and shipment. - Training and supporting site staff on biospecimen kits, labeling, documentation, and shipping requirements. - Monitoring chain-of-custody records, reconciling sample data, and resolving discrepancies promptly. - Overseeing the quality and integrity of biospecimens and ensuring accurate data capture in tracking systems or EDC platforms. - Collaborating with biorepositories, couriers, and laboratories to ensure timely specimen transport and tracking. - Reviewing site documentation for regulatory compliance and ensuring Trial Master File (TMF) completeness. - Providing mentorship and guidance to junior CRAs and site staff. - Performing other responsibilities as assigned by the Clinical Research Manager or management team. Qualifications required for this role include: - 2-3 years of experience as a Clinical Research Associate (CRA), preferably with exposure to biospecimen collection. - Bachelors degree in Life Sciences, Nursing, or a related field; Masters 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 include prior experience in global biobanking initiatives, longitudinal cohort studies, or population-based biospecimen collection programs. Candidates with expertise in biospecimen logistics, familiarity with CAP/CLIA guidelines, and understanding of pre-analytical variables affecting biospecimen quality are preferred. Physical qualifications for this role include standard office duties with minimal physical effort, extensive verbal and written communication skills, and the ability to sit for extended periods. The work schedule is full-time hybrid, with work hours adjusted to align with U.S. Daylight Saving Time.,