Senior Clinical Research Associate - Remote GI Trials

Alimentiv-2; San Diego (CA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Education Reimbursement

Cell Phone Allowance & Remote Work

Office setup allowance

Visits program (up to 4 weeks)

Flexible Summer Hours

Employee referral incentive

Alimentiv Trust eligibility

Mentorship program

Job summary

Alimentiv, a global CRO focused on GI therapies, seeks a Senior Clinical Research Associate to independently monitor sites, coordinate start-up through close-out, and mentor junior CRAs. You will liaise with investigative sites and sponsors, ensuring data integrity and regulatory compliance across studies.

The role requires strong communication, travel up to 60%, and proficiency with EDC systems and TMF/CTMS tools. Join a private, growth-focused team with competitive benefits.

Qualifications

• Honours bachelor’s degree in health or life sciences; master’s preferred.
• 4–6 years in clinical research; 7–9 years preferred.
• Experience across Phase I–IV trials.
• ICH-GCP knowledge and local regulatory requirements.
• Experience with site qualification, initiation, monitoring and close-out visits.
• Proficient with EDC systems (Medidata Rave, Oracle InForm) and related tools.

Responsibilities

• Independently conduct on-site and remote monitoring visits per SOPs.
• Be primary contact for investigative sites; manage questions and deviations.
• Review source data and queries for accuracy and compliance.
• Oversee site activation and ongoing management to meet timelines.
• Ensure training on study protocols and regulatory requirements.
• Review ISF, TMF and study systems for completeness and timeliness.
• Coordinate site-related activities and communications with cross-functional teams.
• Support start-up, regulatory and translation activities as needed.
• Participate in meetings, audits and inspections; support issue resolution.
• Mentor CRA I/II; contribute to training and process improvements.

Education

Bachelor’s degree in Health/Life Sciences

Master’s degree (asset)

Tools

Medidata Rave

Oracle InForm

eTMF

CTMS

Microsoft Office

Job description

Alimentiv, a global CRO focused on GI therapies, seeks a Senior Clinical Research Associate to independently monitor sites, coordinate start-up through close-out, and mentor junior CRAs. You will liaise with investigative sites and sponsors, ensuring data integrity and regulatory compliance across studies.

The role requires strong communication, travel up to 60%, and proficiency with EDC systems and TMF/CTMS tools. Join a private, growth-focused team with competitive benefits.