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 and client company personnel. May assist project manager or clinical team manager on assigned projects and / or may assist in the mentoring and training of junior clinical team members.
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.
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.
Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements & share potential solutions for improvements.
g. Clinical Trial Management System, CTMS). Perform QC check of reports generated from CTMS system where required.
Education and Experience :
Bachelor's degree in a life science 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 3+ 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 :
Effective clinical monitoring skills
Excellent understanding and demonstrated application of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
Well-developed critical thinking skills, including but not limited to : critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
Manages Risk Based Monitoring concepts and processes
Ability to mentor and train other monitors in a positive and effective manner
Ability to evaluate medical research data and proficient knowledge of medical terminology
Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
Excellent interpersonal skills
Strong attention to detail Effective organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Excellent team player with team building skills
Ability to work independently as required
Ability to utilize problem-solving techniques applicable to constantly changing environment
Good computer skills : proficient knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
Effective presentation skills
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.