Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Essential Functions and Other Job Information:
Monitors investigator sites with particular ability to manage complex studies
Functions and/or challenging sites using 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
Provides updates on potential trends noted across multiple sites and discusses
potential strategies for their management to the Clinical Team Manager (CTM).
Supports Clinical Team Management, including or Clinical Manager of CRAs (CMCRA), to mentor, train and contribute to the development of junior CRAs. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements, share potential solutions & implement where appropriate.
Facilitates effective communication between investigative sites, the client
company and the PPD project team through written, oral and/or electronic
contacts
Provides trial status tracking and progress update reports to the Clinical Team
Manager (CTM) as required. Ensures study systems are updated per agreed
Qualifications:
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.
Considerable clinical research monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) with a demonstrated high level of expertise in all aspects of clinical monitoring.
Valid driver's license where applicable
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.
Must be able to comply with specific sponsor/client/site requirements, even if not required by Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site.