Job Description
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. 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 and Other Job Information:
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. Job Complexity Works on problems of limited scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Job Knowledge Learns to use professional concepts. Applies company policies and procedures to resolve routine issues. Supervision Received Normally receives detailed instructions on all work. Business Relationships Contacts are primarily with immediate supervisor, and other personnel in the department. Builds stable working relationships internally.
Qualifications:
Education and Experience: Bachelor's degree in a life sciences related fieldor 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. Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
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 GCPs and applicable SOPs · 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 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 · Good presentation skills