Clinical Research Coordinator I

6 days ago

Durham North Carolina, United States Durham - Clinical Site Full time
About Durham - Clinical Site

Durham - Clinical Site is a leading research organization dedicated to delivering high-quality clinical trials and exceptional patient care. Our team of experts is committed to advancing medical research and improving patient outcomes.

Job Summary

We are seeking a highly skilled Clinical Research Coordinator I to join our team. The successful candidate will be responsible for conducting and managing clinical trials in accordance with study protocols, Good Clinical Practice (GCP), and our Standard Operating Procedures (SOPs).

Key Responsibilities
  • Conduct and manage clinical trials in accordance with study protocols, GCP, ICH Guidelines, and our SOPs
  • Coordinate clinical trials, including start-up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, and ensuring data is entered in a timely manner
  • Implement research and administrative strategies to successfully manage assigned protocols
  • Communicate effectively with coworkers, leadership, study subjects, sponsors, Contract Research Organizations (CROs), and vendors
  • Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries
  • Maintain confidentiality of patient protected health information, sponsor confidential information, and company confidential information
  • Ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and our SOPs
  • Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
  • Delegate and train staff appropriately and document
  • Create, collect, and submit regulatory documents to sponsors and Institutional Review Boards (IRBs) as required per protocol, GCP/ICH regulations, and IRB requirements
  • Evaluate potential subjects for participation in clinical trials, including phone and in-person prescreens
  • Execute recruitment strategies defined by the Clinical Research Team
  • Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol
  • Perform clinical duties within scope, including drug preparation and administration, fibroscan, phlebotomy, ECG, and lab processing
  • Promote respect for cultural diversity and conventions with all individuals
Requirements
  • Bachelor's degree with 1 year of relevant experience in the life science industry
  • Associate's degree with 2 years of relevant experience in the life science industry
  • High School Graduate and/or technical degree with a minimum of 3 years of relevant experience in the life science industry
  • Phlebotomy certification if applicable and required by state law
  • Intramuscular dose administration and preparation certification if applicable and required by state law
Preferred Qualifications
  • Demonstrated knowledge of medical terminology
  • Demonstrated ability to use technology, including computers, Microsoft Office software, fax, copier, and multi-line telephone
  • Demonstrated ability to work in a fast-paced environment
  • Demonstrated verbal, written, and organizational skills
  • Demonstrated interpersonal and communication skills
  • Demonstrated ability to work as a team player
  • Demonstrated ability to read, write, and speak English
  • Demonstrated ability to multi-task
  • Demonstrated ability to follow written guidelines
  • Demonstrated ability to work independently, plan, and prioritize with some guidance
  • Demonstrated ability to be flexible and adapt to changing circumstances
  • Must be detail-oriented
  • Demonstrated problem-solving and strategic decision-making ability
Physical Abilities
  • Sit or stand for long periods of time
  • Travel locally and nationally
  • Communicate in person and by telephone
  • Limited walking required
  • Limited lifting up to 30 pounds

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