Clinical Research Associate II/Senior Clinical Research Associate

6 days ago

Birmingham, Birmingham, United Kingdom Pharmiweb Full time
Job Title: Clinical Research Associate II/Senior Clinical Research Associate

At Syneos Health, we are committed to accelerating customer success. We are seeking a highly skilled Clinical Research Associate II/Senior Clinical Research Associate to join our team.

Job Summary:

The Clinical Research Associate II/Senior Clinical Research Associate will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits. The successful candidate will have excellent communication and interpersonal skills, with the ability to work independently and as part of a team.

Key Responsibilities:
  • Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits.
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
  • Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
  • Conduct Source Document Review of appropriate site source documents and medical records.
  • Verify required clinical data entered in the case report form (CRF) is accurate and complete.
  • Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
  • Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
  • Verify site compliance with electronic data capture requirements.
  • Perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
  • Verify the IP has been dispensed and administered to subjects/patients according to the protocol.
  • Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
  • Reconcile contents of the ISF with the Trial Master File (TMF).
  • Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
  • Support subject/patient recruitment, retention, and awareness strategies.
  • Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
Requirements:
  • Oncology Therapeutic area experience.
  • Ability to travel within the UK and Ireland without restrictions.
  • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Must demonstrate good computer skills and be able to embrace new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.
About Syneos Health:

At Syneos Health, we are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

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