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 SOPs.
Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Ensures that data will pass international quality assurance audits.
Develops collaborative relationships with investigational sites. Generally required to travel 60-80% but more for some individuals.
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 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. Manages investigator payments.
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 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.
Education and Experience :
Bachelor's degree in a life sciences related field
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
Knowledge, Skills and Abilities :
Basic medical / therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain a working knowledge of GCPs and applicable SOPs
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
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