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Pharmaceutical Product Development (PPD)

Beijing, Beijing, China

Job Description

Summarized Purpose: PPD’s clinical research associate (CRA) apprenticeship program was developed with military veterans in mind and continues to be a great way for transitioning service members to break into the clinical research industry. This 12-month program provides an accelerated route into the highly demanding CRA role. In this role, your responsibilities will include: - Traveling to client sites to monitor and ensure our studies are conducted both accurately and with integrity. - Obtaining the knowledge, skills, and abilities necessary to become a successful CRA. - Completing required on-the-job training, related instruction and training - Performing investigator file reviews - Prepare project meeting minutes - Perform mass mailings and communications to sites - Process regulatory documents using our Clinical Trial Management System (CTMS) data entry system - Performs remote site management and monitoring activities on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and PPD procedural documents. Increases responsibilities as training is completed and competencies are met. Essential Functions - Completes various training and related instruction and maintains detailed documentation of training completion - Coordinates, oversees and completes administrative functions on assigned trials including, but not limited to, reviewing and transmitting regulatory documents, processing documents sent to file, QC and reconciling project reports, performing mass mailings and faxes, managing and distributing paper study supplies to sites. - Performs PPD investigator file reviews and logs findings in CTMS. - Maintains assigned data points within CTMS according to the established conventions within specified times. - Remotely reviews EDC (with or without source verification, depending on local practice and regulations) and drug accountability log. Performs source data - Verification from web-based sources where possible, and in compliance with local laws. - Writes, follows and resolves clinical queries and issues. - Evaluates, conducts and documents site management contacts according to the monitoring plan and conducts remote study-level training as needed to improve site performance and study compliance. - Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study. - Reviews and appropriately escalates site key risk/performance/quality indicators (SRAP, KRI, KPI, KQI [e.g., early termination and screen-fail rates, average number of open findings, etc.]) , ad-hoc clinical listings review, tracks and trends violations and deviations, ensures visits occurred per the MP, site status, enrollment, CRF status and SAE follow up. - Provides trial status tracking and progress update reports to CTM as required and ensures study systems are updated per agreed study conventions (e.g., CTMS). - Liaises with CRA to promptly collect documents, review data points, findings from EDC and file reviews, etc. Education and Experience: Must be a military veteran or the spouse of an active duty member and/or spouse of a military veteran. Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Previous experience in a medical 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. (After completion of the apprenticeship, this role will be required to travel 60-80%) 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 mand the ability to perceive customers’ underlying issues - Good organizational and time management skills - 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 Working Conditions and Environment: - Work is performed in an office or clinical environment with exposure to electrical office equipment. - Occasional drives to site locations. Potential occasional travel required. - Must pay constant attention to detail-visual, mental. - Must be able to multi-task constantly. - Frequent interaction with clients / associates required. - Long, varied hours required occasionally. - Travel and rotating shifts required on rare occasions. - Exposure to toxic materials 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. - Occasional light lifting and/or carrying of objects with a maximum lift of 5-15 lbs. (2-6 kgs.) - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Ability to communicate 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 andchanging conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. - Regular and consistent attendance. PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.

Job posted: 2023-05-16