CRA II – Sponsor Dedicated, Pulmonary Hypertension Studies

🕒 October 22

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on Syneos Health's careers page, not through a job board

First seen by Remote Rocketship October 22

Still open on Syneos Health's site. Checked 7 minutes ago.

Logo of Syneos Health

Syneos Health

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 recommend site-specific actions • Communicate and escalate serious issues and develop action plans • Verify informed consent, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data in case report forms and resolve queries • Verify compliance with electronic data capture requirements • Manage investigational product inventory, reconciliation, storage, dispensing and administration when required • Review and reconcile Investigator Site Files with the Trial Master File • Document monitoring activities through letters, trip reports, communication logs and project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, status and action items to resolution • Manage site-level activities, communications, budgets and timelines for assigned activities • Act as liaison with study site personnel and ensure site team training and compliance • Attend investigator, sponsor, global monitoring and clinical training meetings • Support audit readiness and audit follow-up actions • Provide site support across the real world late phase study lifecycle • Perform chart abstraction and data collection • Collaborate with sponsor affiliates, medical science liaisons and local country staff • Train junior staff when requested • Identify and communicate out-of-scope activities • Suggest potential sites based on local treatment patterns, patient advocacy and HCP associations

🎯 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 • Ability to manage required travel of up to 75% on a regular basis • Experience in pulmonary hypertension studies • Ability to perform site qualification, initiation, monitoring, management and close-out activities in compliance with regulatory, ICH-GCP/GPP and protocol requirements • Knowledge of local requirements for real world late phase study designs • For US sites, compliance with site requests for medical and other personal information may be required for facility access

🏖️ 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

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