Senior CRA I

🔥 13 hours ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 1 day.
• Jobs at this company usually fill in 21 days.
• No salary listed.

Apply Now

Find Similar Remote Jobs

Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely • Evaluate site and site staff performance and provide recommendations and action plans • Communicate and escalate serious issues to the project team • Verify informed consent processes and protect subject/patient confidentiality • Assess patient safety, clinical data integrity, protocol deviations, violations, and pharmacovigilance issues • Conduct source document review and verify clinical data entered in case report forms • Resolve queries remotely and on site and guide site staff toward resolution • Verify compliance with electronic data capture requirements • Manage investigational product inventory, reconciliation, storage, dispensing, and administration as applicable • Review and reconcile Investigator Site Files with Trial Master Files • Document monitoring activities through letters, trip reports, communication logs, and other project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, status, and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables, and timelines • Liaise with project site personnel and ensure assigned sites and team members are trained and compliant • Prepare for and attend investigator and sponsor meetings • Participate in or lead clinical monitoring/project staff meetings and attend clinical training sessions • Support audit readiness and audit preparation and follow-up • Provide training or mentorship to junior CRAs and perform training/sign-off visits as assigned • Support site activities throughout the study lifecycle for real world late phase studies • Perform chart abstraction and data collection • Collaborate with sponsors, affiliates, medical science liaisons, and local country staff • Identify out-of-scope activities and suggest potential sites • Identify operational efficiencies and process improvements • Develop country-level informed consent forms • Collaborate with regulatory teams and participate in bid defense meetings

🎯 Requirements

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Working knowledge of applicable regulations, company SOPs/processes, and relevant clinical guidance • Knowledge of local requirements for real world late phase study designs, where applicable

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations, when appropriate, for employees or applicants with disabilities

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume