Senior Clinical Research Associate - GI Trials, Remote

Alimentiv

United States

Remote

USD 78,000 - 112,000

Full time

10 days ago

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Benefits offered by this job

Education Reimbursement program for全
Monthly Cell Phone and Remote Work
Office setup allowance
Working while visiting program
Flexible Summer Hours
Employee referral incentive
Company Trust benefits
Alimentorship mentoring
Social events and initiatives

Job summary

Alimentiv is seeking a Senior Clinical Research Associate to lead monitoring and site management across Belgium, ensuring adherence to study protocols, ICH-GCP, and regulatory requirements. You will act as the primary site contact, support recruitment, and oversee essential study documentation while mentoring junior CRAs.

The role requires travel, strong communication, and a proven track record in site management for complex trials.

Qualifications

  • Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, Nursing or related discipline; Master’s preferred.
  • 4–6 years clinical research experience; 7–9 years preferred.
  • Strong clinical site monitoring experience from start-up through close-out.
  • Thorough knowledge of ICH-GCP, clinical research principles and local regulations.
  • Experience with Phase I–IV clinical trials preferred.
  • Proficiency with EDC, IRT, eTMF, CTMS and MS Office; Medidata Rave or Oracle InForm preferred.
  • Strong site management knowledge: activation, recruitment, training, documentation.
  • Excellent communication and relationship-management skills with sponsors and teams.

Responsibilities

  • Independently conduct onsite and remote monitoring across Belgium.
  • Ensure sites comply with protocols, ICH-GCP and regulations.
  • Serve as primary contact for sites, managing queries and deviations to resolution.
  • Review trial data and source documents for accuracy and integrity.
  • Support site selection, activation and recruitment to meet milestones.
  • Train sites on protocols, systems and requirements throughout the study.
  • Maintain essential study documents (ISF and TMF).
  • Collaborate with sponsors, project teams and vendors to meet timelines.
  • Participate in audits, Investigator Meetings and study meetings.
  • Mentor CRA I/II colleagues and contribute to process improvements.

Skills

Site monitoring
ICH-GCP knowledge
Communication skills
Travel readiness
Mentoring

Education

Bachelor’s degree in Life Sciences
Master’s degree preferred

Tools

EDC
IRT
eTMF
CTMS
Medidata Rave
Oracle InForm

Job description

Alimentiv is seeking a Senior Clinical Research Associate to lead monitoring and site management across Belgium, ensuring adherence to study protocols, ICH-GCP, and regulatory requirements. You will act as the primary site contact, support recruitment, and oversee essential study documentation while mentoring junior CRAs.

The role requires travel, strong communication, and a proven track record in site management for complex trials.

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