Summarized Purpose :
Performs and coordinates all aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
Manages procedures and guidelines from different sponsors and / or monitoring environments (i.e. FSO, FSP, Government, etc.
Acts 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.
Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Essential Functions :
Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review.
Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process.
Ensures a shared responsibility with other project team members on issues / findings resolution. Investigates and follows-up on findings as applicable
g. Clinical Trial Management System, CTMS). Performs QC check of reports generated from CTMS system where required.
Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
Ensures trial close out and retrieval of trial materials.
Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
Education and Experience :
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years as a clinical research monitor).
Valid driver's license where applicable.
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.
Knowledge, Skills and Abilities :
Working Environment :
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment / requirements for this role :
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
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.