Summarized Purpose :
Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOP's.
Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Ensures that data will pass international quality assurance audits.
Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites.
Generally required to travel 60-80% but more for some individuals.
Essential Functions :
Monitors investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records / clinic notes (source document verification).
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, present potential solutions and follow all issues through to resolution.
Maintains 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 investigator meetings as necessary. Identifies 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.
Manages the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.
g. Clinical Trial Management System).
Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and / or electronic contacts.
Responds to company, client and federal regulatory requirements / audits.
Maintains & 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.
Other project work as assigned.
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 1 years as a clinical research monitor)
or completion of PPD Drug Development Fellowship or equivalent combination of education, training, & experience.
Valid driver's license where applicable.
Knowledge, Skills and Abilities :
Proven clinical monitoring skills
Demonstrated understanding of medical / therapeutic area knowledge and medical terminology
Demonstrated ability to attain and maintain a working knowledge of GCP's and applicable SOP's
Good 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
Good organizational and time management skills
Effective interpersonal skills
Attention to detail
Ability to remain flexible and adaptable in a wide range of scenarios
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
Good presentation 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.
Requisition ID : 156563