Clinical Research Associate

The in-house Clinical Research Associate (CRA) reports to the Director/Associate Director, Clinical Operations.  The CRA works cross functionally with the Clinical Development and Medical Affairs (CDMA) team to support study activities as defined by clinical protocols and corporate objectives. The CRA contributes to the successful execution of clinical trials from protocol concept through the clinical study report, ensuring completion of all deliverables and adherence to all country, state, and local regulatory requirements.

Responsibilities

  • Prepare, review and, revise clinical trial protocols, reports and other study documentation, including Investigator Brochure
  • Interface with CROs and consultants to review documentation and manage workflow to ensure trial progress
  • Execute efficient IRB Submissions and closure reports, ensuring timely ethical review
  • Manage distribution, collection, and tracking of regulatory documentation and clinical supplies to ensure compliance at both site and sponsor trial master files
  • Create, populate, and manage paper and electronic study documentation, Case Report Forms (CRFs), training materials, and study binders following GCP/ICH guidelines
  • TMF and eTMF maintenance
  • Train medical professionals on study conduct requirements, source documentation, and Electronic Data Capture system at site initiations and monitoring visits
  • Perform site visits, co-monitoring visits to ensure protocol and regulatory compliance and effectively resolve site related issues
  • Participate in data reviews; issue data queries and support resolution to ensure accurate data submission
  • Position will require some travel (10-15%)

Education and Experience Requirements

  • Have either a degree or postgraduate qualification in nursing, life sciences or medical sciences
  • Excellent communication skills (both written and oral) and the ability to build effective relationships with trial center staff and colleagues
  • The ability to motivate others
  • The ability to multi-task and think on your feet
  • Good organizational, IT and administrative skills – the job involves a lot of documentation and recording of information through computerized processes such as clinical trial management systems and electronic data capture
  • Detailed knowledge of good clinical practice (GCP)
  • Background in FDA 21 CFR Parts 210, 211 and 820; ISO 13485; European Medical Device Directive; and IEC 60601-1
  • Background with drug/device combination product regulations and procedures is preferred

 Skills and Abilities

  • You are passionate about your work and display a high level of emotional intelligence in your decision making
  • You understand, appreciate, and thrive in a growing organization and have the desire to learn new skills to contribute to company success
  • You are a good problem solver and able to deliver on commitments
  • You act with impeccable integrity and treat your colleagues, business partners, and customers with the utmost respect
  • You have excellent communication, customer service and collaborative skill
  • You strive for excellence and expect the same from your team and colleagues

scPharmaceuticals is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.