Job Description

　　Summarized Purpose:

　　Performs and coordinates different 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

　　Monitors investigator sites with a risk-based monitoring approach: applies 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. 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.

　　Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. 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. Performs trial close out and retrieval of trial materials.

　　Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.

　　Provides trial status tracking and progress update reports to the team as

　　required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System).

　　Facilitates effective communication between investigative sites, the client

　　company and internal project teams through written, oral and/or electronic

　　contacts. Responds to company, client and applicable regulatory

　　requirements/audits/inspections.

　　Maintains and completes administrative tasks such as expense reports and

　　timesheets in a timely manner.

　　Contributes to the project team by assisting in preparation of project

　　publications/tools and sharing ideas/suggestions with team members.

　　Contributes to other project work and initiatives for process improvement, as

　　required.

　　Qualifications:

　　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.

　　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, medical terminology, medical research, clinical research or health care or experience in a health sciences field

　　with formal training in medical terminology and anatomy may be considered.

　　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:

　　Basic medical/therapeutic area knowledge and understanding of medical terminology

　　Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents

　　Good oral and written communication skills, with the ability to communicate effectively with medical personnel

　　Good interpersonal skills

　　Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues

　　Good organizational and time management skills

　　Ability to remain flexibile and adaptable in a wide range of scenarios

　　Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving

　　Ability to manage Risk Based Monitoring concepts and processes

　　Ability to work in a team or independently as required

　　Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software

　　Good English language and grammar skills