Cra (Level I)

hace 4 semanas

Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

As a PPD CRA, you will perform and coordinate all aspects of the clinical monitoring and site
management process. At PPD we hire the best, develop ourselves and each other, and recognize the
power of being one team. We offer continued career advancement opportunities, award winning training
and benefits focused on the health and wellbeing of our employees. 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 monitoring 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
relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in
the task matrix. Essential Functions: - 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 all 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 monitoring 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 follow-up
on findings as applicable. - Participates in investigator meetings as necessary. May help to identify
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. - Ensures that required essential documents are
complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as
per project specifications. - Provides trial status tracking and progress update reports to the team as
required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g.
Clinical Trial Management System). - Facilitates effective communication between investigative sites, the
client company and internal project teamsthrough written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. - 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. - Contributes to other project work and initiatives for process improvement, as required.
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. 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 with formal
training in medical terminology and anatomy may be considered. Valid driver's license where applicable.
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or
directly related experience, will be considered sufficient for an individual to meet the requirements of the
role. Knowledge, Skills and Abilities: - Basic medical/therapeutic area knowledge and understanding of
medical terminology - Ability toattain and maintain a working knowledge of ICH GCPs and applicable
regulations and - procedural documents - 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 de

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