[Hiring] Senior Clinical Research Associate @Alimentiv

Role Description

The Senior Clinical Research Associate (Sr. CRA) independently performs, coordinates and oversees clinical site monitoring activities, ensuring compliance with study protocols, Alimentiv and sponsor procedures, ICH-GCP guidelines and local regulatory requirements.

Serving as a primary liaison between investigative sites, Alimentiv and sponsors, the Sr. CRA plays a key role in the successful execution of clinical studies from site selection and start-up through monitoring and close-out. This role also provides guidance and mentorship to CRA I and CRA II colleagues and may participate in CRA assessment visits, co-monitoring activities, audits and inspections.

Key Responsibilities

• Independently conduct and document onsite and remote site management activities, including site qualification, initiation, monitoring and close-out visits, in accordance with applicable SOPs and study requirements.
• Serve as a primary point of contact for investigative sites, building effective working relationships and ensuring site questions, issues, action items and protocol deviations are followed through to resolution.
• Review source documentation and study systems to ensure clinical data is accurate, complete and compliant with protocol, regulatory and study requirements; manage and facilitate the resolution of data queries.
• Oversee site activation and ongoing site management activities, working with sites and cross-functional teams to achieve project timelines, milestones and recruitment objectives.
• Ensure site personnel are appropriately trained on study protocols, plans, systems, ICH-GCP requirements and project-specific expectations.
• Routinely review Investigator Site Files (ISF), Trial Master Files (TMF) and study systems for accuracy, completeness, timeliness and compliance, requesting outstanding documentation as required.
• Coordinate site-related study activities and communications, including clinical supplies, investigational product, laboratory materials, ePROs, study documentation and ongoing project updates.
• Collaborate with Study Start-up, Regulatory and other cross-functional teams, including supporting document collection, localisation and translation activities where required.
• Participate in study meetings, Investigator Meetings, audits and inspections, supporting issue resolution and implementation of corrective actions when required.
• Mentor and support CRA I and CRA II colleagues, including CRA Assessment Visits, co-monitoring and sign-off activities; contribute to CRA interviews, training and process improvement initiatives as requested.

Qualifications

• (Honours) Bachelor’s degree required; a degree in Health Sciences, Life Sciences, Pharmacy or Nursing is preferred. A Master’s degree is considered an asset.
• Minimum 4–6 years of relevant clinical research experience; 7–9 years of related experience is preferred.
• Experience across Phase I–IV clinical trials is preferred.
• Thorough knowledge of ICH-GCP and applicable local regulatory requirements.
• Demonstrated experience independently conducting site qualification, initiation, monitoring and close-out visits.
• Proficiency with clinical trial systems including EDC platforms (e.g., Medidata Rave, Oracle InForm), IRT, eTMF and CTMS, as well as Microsoft Office.
• Strong interpersonal, communication and problem-solving skills, with the ability to work independently and effectively within cross-functional teams.
• Strong organisational skills, attention to detail and the ability to manage priorities with an appropriate sense of urgency.
• Fluent written and verbal English; an equivalent combination of education and relevant experience may be considered.
• Valid driver’s licence and ability to travel approximately 40–60%, depending on project assignment and the geographic location of investigative sites.

Benefits

• Education Reimbursement program for full-time employees.
• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility).
• One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.).
• Working while visiting program – up to 4 weeks per year!
• Flexible Summer Hours Program from May – September.
• Employee referral incentive – we know great people know other great people, and we think that warrants recognition!
• Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment.
• Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with your seniority; social committee and several other optional initiatives designed to support you in feeling like part of the Alimentiv team!
• Additional benefits may be available depending on the country of employment and are subject to local policies and eligibility.