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Clinical Research Coordinator

Randstad Life Sciences
Asheville, NC
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Summary of Key Responsibilities:

Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and monitoring while the subjects are on study. Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports.

Duties and Responsibilities:

  • Supports enrolling patients onto the clinical trial through screening, enrollment and follow up of eligible subjects according to protocol requirements
  • Ensures the protection of study patients by verifying informed consent procedures and adheres to protocol requirements/compliance
  • Collects, completes, and enters data into study specific case report forms or electronic data capture systems
  • Ensures timely and accurate data completion
  • Collects blood samples and tracks shipments and requests supplies as needed
  • Implements study-specific communications
  • Ensures timely adherence to protocol requirements
  • Responsible for completion of all required documentation
  • Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, subject logs and study-related communications
  • Communicates all study-related issues to appropriate study colleagues or manager
  • Apprises principal investigator and management of all study specific medical issues for guidance
  • Attends study specific meetings as required or asked to do so
  • Reviews and responds to any monitoring findings and escalates issues
  • Organizational and prioritizing capabilities
  • Computer skills with demonstrated abilities using web-based applications, electronic data capture, and MS Word or Excel
  • Professional communication
  • Communicate and work effectively with a diverse team of professional
  • Interpersonal skills, detail-oriented and meticulous
  • Work independently in a fast pace environment with minimal supervision at off-site facilities

What Qualifications You Will Need

  • Knowledge of federal regulations, good clinical practices (GCP)
  • Knowledge of medical and research terminology
  • Computer skills including use of clinical trial database, electronic data capture, and MS Word or Excel
  • Excellent Verbal and written communication skills
  • Excellent interpersonal skills
  • The ability to communicate and work effectively with a diverse team of professionals
  • Organizational and prioritizing capabilities
  • The ability to work independently in a fast pace environment with minimal supervision at off-site facilities
  • At least one year of experience as a Clinical Research Coordinator
  • Nursing experience is preferred

Job Summary And Qualifications

  • You will support enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements
  • You will be responsible for working with the principal investigator to meet or exceed study enrollment.
  • You will review the study design and inclusion/exclusion criteria with physician and patient
  • You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements/compliance
  • You will ensure the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data
  • You will create study specific tools for source documentation when not provided by sponsor
  • You will collect, complete, and enter data into study specific case report forms or electronic data capture systems
  • You will generate and track drug shipments, device shipments, and supplies as needed
  • You will report and follow up on serious adverse events as necessary
  • You will implement study-specific communications
  • You will ensure timely adherence to protocol requirements
  • You will be responsible for completion of all required documentation according to site works guidelines
  • You will ensure timely and accurate data completion
  • You will maintain accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs and study-related communications
  • You will track and report adverse events, serious adverse events, protocol waivers, deviations, and violations
  • You will communicate all protocol-related issues to appropriate study colleagues or manager
  • You will attend study specific on site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so
  • You will apprise the principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance
  • You will assist sponsor and US FDA audit teams
  • You will review and respond to any monitoring and auditing findings and escalates issues defined by Regional Site Manager

Randstad Life Sciences

Address

Asheville, NC
USA

Industry

Healthcare

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