CRA II/Sr CRA, Phase I

🕒 September 28

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🗣️🇩🇪 German Required

Where this job comes from

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

First seen by Remote Rocketship September 28

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 provide recommendations on site-specific actions • Communicate and escalate serious issues to the project team and develop action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Conduct source document review and verify clinical data in case report forms • Resolve queries remotely and on site within agreed timelines • Support clinical study data review and capture using available hardware and software • Verify site compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation, storage and administration reviews • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through required project documents and tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communication to meet project objectives, deliverables and timelines • Act as liaison with project site personnel and ensure assigned sites and team members are trained and compliant • Prepare for and attend Investigator Meetings, sponsor meetings, clinical monitoring meetings and training sessions • Support audit readiness and audit preparation follow-up actions • Provide training or mentorship to junior CRAs and perform training and sign-off visits as assigned

🎯 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 • Experience as CRA with a strong background in oncology clinical trials across all phases of development, including early phase/first-in-human studies, safety, PK/PD, and dose-escalation designs • Good computer skills and ability to embrace new technologies • Hands-on experience supporting solid tumor indications such as melanoma, breast, ovarian, prostate, and lung cancer is ideal • Prior exposure to investigational products involving Toll-Like Receptor (TLR) pathways, PARP1 inhibitors, or Werner helicase protein is desirable but not required • Phase I oncology experience is essential • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • Multilingual capabilities: English and German • Ability to manage required travel of up to 75% on a regular basis

🏖️ Benefits

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

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