Senior Clinical Research Associate – CRO-Contract

🔥 3 minutes ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $0 - $110 / hour

⏳ Contract/Temporary

🟠 Senior

🧪 Clinical Research

👻 Ghost score 1%

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Evolution Research Group

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Evolution Research Group is a clinical research organization dedicated to advancing medical science through innovative clinical trials. Specializing in therapeutic areas such as psychiatry, neurology, pain management, addiction, and various chronic conditions, ERG collaborates with healthcare providers and advocacy organizations to ensure inclusivity and thorough patient recruitment. With a robust database of potential participants and expertise in early-phase trials, Evolution Research Group aims to transform healthcare by supporting the development of life-changing therapies.

📋 Description

• Independently manage and monitor site activities for assigned clinical studies • Conduct site qualification, site initiation, interim monitoring, and close-out visits • Ensure compliance with protocols, Lotus or Sponsor SOPs, FDA regulations, and ICH-GCP guidelines • Perform site evaluation visits and assess investigators’ site capabilities • Conduct study initiation activities, review protocols and regulatory issues, and train site personnel • Ensure Investigator Site Files remain audit-ready and documents are uploaded to the Trial Master File • Communicate with investigational sites regarding visit planning, query resolution, action items, and site management • Document clinical trial material accountability, stability, and storage conditions; perform investigational product inventory • Coordinate site correspondence and ensure timely transmission of clinical data • Perform close-out visits, investigational product reconciliation and disposition, study file reconciliation, query resolution through database lock, and outstanding action-item resolution • Complete internal and study-related training within required timelines • Complete pre- and post-visit follow-up, including confirmation letters, follow-up letters, and monitoring visit reports • Collaborate with the CRA Line Manager on mentoring, training, and assessment of CRAs and junior staff as applicable

🎯 Requirements

• Bachelor's degree or equivalent experience in life science/healthcare • At least 5 years of field experience working within clinical research as a CRA • Mastery of the CRA II Job Responsibilities • Valid Driver’s License • Legally authorized to work in the US as an independent contractor (LLC or INC.) or through an agency • Ability and willingness to travel up to 100% of the time, both domestically by land and air • Expert knowledge of the drug development process, ICH guidelines, GCP, and the clinical trial process • Proficiency in using electronic CRF platforms and processes • Excellent interpersonal, organizational, and multitasking skills • Exceptional attention to detail and professional judgment • Ability to uphold ICH GCP guidelines and determine appropriate action for complex problems • Ability to manage multiple deadlines and work independently • Proficient computer skills and working knowledge of email, document, spreadsheet, and presentation software • Ability to submit invoices and expense reports timely according to Finance Department requirements • Ability to meet physical demands including occasional lifting/carrying up to 10 pounds • Must follow safety, environmental, infection control, and protective-equipment requirements when traveling or visiting clinical research sites

🏖️ Benefits

• Contractor is responsible for their own insurance • Home office environment option • Opportunity to support mentoring, training, and assessment of CRAs and junior staff