Clinical Operations Specialist

4 weeks ago

Melbourne, Victoria, Australia Thermo Fisher Scientific Full time

Job Summary:
We are seeking a highly skilled Clinical Operations Specialist to join our team at Thermo Fisher Scientific. As a Clinical Operations Specialist, you will be responsible for conducting remote or on-site visits to assess protocol and regulatory compliance and managing required documentation. You will also manage procedures and guidelines from a specific sponsor (in an FSP setting) and various monitoring environments. Additionally, you will act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

A Day in the Life:
As a Clinical Operations Specialist, you will monitor investigator sites with a risk-based monitoring approach, applying root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. You will assess investigational product through physical inventory and records review. You will raise observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. You may need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that identified issues are being resolved and that the data is being recorded. You will participate in investigator meetings, initiate clinical trial sites to ensure compliance and perform trial close out and retrieval of trial materials. You will conduct on-site file reviews.

Keys to Success:
To be successful in this role, you will need a Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. You will also need minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials. 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. You will also need a valid driver's license.

Work Environment:
Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. As a Clinical Operations Specialist, you will be able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. You will be able to work upright and stationary for typical working hours. You will be able to work in non-traditional work environments. You will be able to use and learn standard office equipment and technology with proficiency. You will be able to perform successfully under pressure while prioritizing and balancing multiple projects or activities. You may have exposure to potentially hazardous elements typically found in healthcare or laboratory environments. This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains. This position requires overnight travel either regionally or nationally, dependent on business needs. As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

Location/Division Specific Information:
This home-based position requires candidates to currently live in one of the following cities: Sydney, Melbourne, Brisbane, Adelaide or Perth.

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