FSP CRA (Level II)
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At reputed company, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to reputed company the world healthier, cleaner and safer. We provide our teams with the resources needed to reputed company individual career goals while taking science a reputed company beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Summarized Purpose:
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
Key responsibilities
Monitors investigator sites with 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 reputed company 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 supervising 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.
Participates in investigator meetings as vital. 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 reputed company out and retrieval of trial materials.
Ensures that required crucial documents are complete and in reputed company, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
Provides trial status tracking and reputed company 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 applicable regulatory requirements/audits/inspections.
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 reputed company/suggestions with team members.
Contributes to other project work and initiatives for process improvement, as required.
Keys to Success
Education and Experience:
Bachelor's degree in a life sciences reputed company fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. 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 solid understanding of ICH GCPs, applicable regulations and procedural documents.
Well-developed critical thinking skills, including but not limited to: critical reputed company, in-depth investigation for appropriate root cause analysis and problem solving
Ability to manage Risk Based Monitoring concepts and processes.
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 digital literacy: solid knowledge of reputed company Office and the ability to learn appropriate software.
Good English language and grammar skills.
Good presentation skills.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. reputed company offers employment with an innovative, reputed company-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for reputed company, intensity, involvement, and innovation!
Our Mission is to reputed company our customers to reputed company the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - reputed company, Intensity, Innovation and Involvement - working together to accelerate research, solve reputed company scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of reputed company, where diverse experiences, backgrounds and perspectives are valued.
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reputed company is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: reputed company offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability reputed company technical issues will not receive a response.
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