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We are seeking a Lead Clinical Research Coordinator to join our site in Phoenix, AZ!

 

#LI-JD1

  • Acts as the lead and subject matter expert in conducting clinical studies according to FDA/GCP and ICH regulations and guidelines.
  • Provides medical care to patients, always ensuring patient safety comes first.
  • Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
  • Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, blood samples, etc.).
  • Records all patient information and results from test as per protocol on the required forms.
  • Where required, may complete IP accountability logs and associated information.
  • Reports suspected non-compliance to relevant site staff.
  • Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
  • Promotes the company and builds a positive relationship with patients to ensure retention.
  • Attends site initiation meetings and all other relevant meetings to receive training on protocol.
  • Reviews the overall plan for study conduct for multiple assigned studies and determines how to accomplish. Identifies and communicates any obstacles impeding efficient study conduct.
  • Accurately collects and documents data. Ensures correct study documents and computer-generated forms are used in compliance with protocol.
  • Ensures that timelines are met by working with relevant staff.
  • Monitors safety and well-being of all study participants through direct and indirect interaction with subjects, and communicates problems to relevant stakeholders.
  • Performs clinical assessments of participants, monitors laboratory safety reports, and communicates any serious or potentially serious adverse events as per the company procedure.
  • Serves as a primary point of sponsor contact for all research activities for studies assigned.
  • Ensures all communications are documented and shared with the appropriate team members.
  • Acts as a back-up to direct people manager. This includes but is not limited to, overseeing and assigning work to team members, scheduling, and monitoring time. Involved in the interview and hiring process of new team members. Assists in the training of new team members and provides mentoring. Provides input into evaluations performance reviews of team members. Performs other study related duties as qualified by documented training.
  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  • Good understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
  • Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving
  • Demonstrated ability to exercise discretion and sound judgement
  • Adequate decision-making, negotiation and influencing skills
  • Decent communication skills and English fluency will be an advantage
  • Decent organizational skills
  • Essential proficiency in basic computer applications
  • Decent interpersonal skills to work in a team environment

We offer a comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!  

We are an Affirmative Action and Equal Opportunity Employer.

Accelerated Enrollment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrollment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

The array of  AES services include strategic enrollment solutions that offer speed, certainty and commercial value to our clients. Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.