CRA II/ SCRA (Sydney/ Brisbane/ Melbourne)
Updated: Yesterday
Location: Adelaide, SA, Australia
Job ID:25105425
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 and put patients at the center of everything we do.
Job Responsibilities
* Perform site qualification, initiation, interim monitoring, ongoing site management activities, and close‐out visits, ensuring regulatory, ICH‐GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
* Verify informed consent processes, maintain confidentiality, and assess factors that may affect subject safety and data integrity, including protocol deviations and pharmacovigilance issues.
* Apply the Clinical Monitoring/Site Management Plan to assess site processes, conduct source document review, verify accuracy of data entered in Case Report Forms (CRFs), and drive query resolution to closure.
* Manage investigational product (IP) inventory, reconciliation, dispensing, and storage, ensuring correct labeling, importation, release, and return according to GCP and local regulations.
* Review Investigator Site File (ISF) for accuracy, timeliness, and completeness, reconciling with the Trial Master File (TMF) and ensuring compliance with archiving regulations.
* Document activities via confirmation letters, follow‐up letters, trip reports, and communication logs; enter data into tracking systems, and monitor action items to resolution.
* Manage project scope, budgets, and timelines at the site level; adapt quickly to changing priorities and communicate project objectives, deliverables, and milestones.
* Act as primary liaison with study site personnel, ensuring all site staff are trained and compliant with applicable requirements.
* Prepare for and attend investigator meetings, sponsor face‐to‐face meetings, global clinical monitoring/project staff meetings, and required training sessions.
* Provide guidance toward audit readiness, support audit preparation, and follow‐up on audit findings.
* Maintain working knowledge of ICH/GCP guidelines and other regulatory requirements; complete required training.
* Support site lifecycle activities from identification through close‐out, chart abstraction, data collection, and collaborating with sponsor affiliates, medical science liaisons, and local staff.
Qualifications
* Bachelor's degree or RN in a related field, or an equivalent combination of education, training and experience.
* Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
* Proficient computer skills and willingness to adopt new technologies.
* Excellent communication, presentation, and interpersonal skills.
* Ability to manage required travel of up to 75% on a regular basis.
* U.S. candidates only: compliance with employment privacy and facility access requirements as outlined by Syneos Health.
Additional Information
The Company shall provide equal opportunity employment in compliance with applicable laws and regulations. We are committed to compliance with the Americans with Disabilities Act, including reasonable accommodations, as appropriate, to assist employees or applicants to perform essential functions of the job.
#J-18808-Ljbffr