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
Management Role:
No management responsibility
Working Conditions and Environment:
Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to
electrical office equipment.
Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals.
May also include extended overnight stays.
Exposure to biological fluids with potential exposure to infectious organisms.
Personal protective equipment required such as protective eyewear, garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
Physical Requirements:
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements
of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop
computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate complex information and ideas so others will understand; with the ability to
listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions
with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.
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