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CRA II (Sponsor dedicated)
CRA II (Sponsor dedicated)Syneos Health • Auckland, Auckland, New Zealand
CRA II (Sponsor dedicated)

CRA II (Sponsor dedicated)

Syneos Health • Auckland, Auckland, New Zealand
1 day ago
Job description

CRA II (Sponsor dedicated)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and to work for.

Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovate as a team, and help our customers achieve their goals. We are agile, driven, and passionate about accelerating the delivery of therapies to change lives.

WORK HERE MATTERS EVERYWHERE

  • We are passionate about developing our people through career development, progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. This culture unites us globally and we are dedicated to taking care of our people.
  • We continuously build the company we all want to work for and our customers want to work with. Diversity of thoughts, backgrounds, cultures, and perspectives create a place where everyone feels they belong.

Job Responsibilities

  • Perform site qualification, site initiation, interim monitoring, site management activities and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP, and Good Pharmacoepidemiology Practice (GPP) compliance.
  • Verify informed consent processes, protect subject confidentiality, assess safety factors, and handle protocol deviations, violations, and pharmacovigilance issues.
  • Assess site processes, conduct source document review, verify CRF data accuracy, apply query resolution techniques, and ensure electronic data capture compliance.
  • Perform investigational product (IP) inventory, reconciliation, storage, and security; verify IP dispensing and administration per protocol; handle IP risks and recordkeeping.
  • Review the Investigator Site File (ISF) for accuracy and reconcile with the Trial Master File (TMF); ensure archiving requirements are met.
  • Document activities through letters, trip reports, and logs; support recruitment, retention, and awareness strategies.
  • Understand project scope, budgets, and timelines; manage site‑level activities to meet objectives.
  • Act as liaison with study site personnel; train and ensure compliance.
  • Attend investigator meetings, sponsor face‑to‑face meetings, project staff meetings, and training sessions.
  • Guide audit readiness and support audit preparation.
  • Maintain knowledge of ICH / GCP and company SOPs; complete required training.
  • For Real World Late Phase, use the Site Management Associate II title and provide site support throughout the study lifecycle, chart abstraction, data collection, and collaboration with sponsor affiliates.
  • Qualifications

  • Bachelor’s degree or RN in a related field or equivalent education, training, and experience.
  • Knowledge of Good Clinical Practice / ICH Guidelines and regulatory requirements.
  • Good computer skills and ability to embrace new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Ability to manage required travel of up to 75% on a regular basis.
  • US‑ONLY : As part of employment with Syneos Health, you may be deployed to sites requiring certain medical and personal information for access. You must comply with site requests; failure may result in entry denial and employment risk.
  • Additional Information

    Tasks, duties, and responsibilities are not exhaustive. The company may assign other duties and determine equivalence in qualifications. The company complies with the Americans with Disabilities Act and the EU Equality Directive.

    Summary

    Roles within Clinical Monitoring / CRA oversee and ensure the integrity of clinical research studies, conduct remote monitoring, identify potential issues, and collaborate with site teams to enhance quality monitoring and trial success. This role may manage a small team and requires advanced education and practical professional knowledge.

    Seniority level

    Mid‑Senior level

    Employment type

    Full‑time

    Job function

    Research, Analyst, and Information Technology

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    Ii Sponsor Dedicated • Auckland, Auckland, New Zealand

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