FSP CRA (Level II)

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific,   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 make the world healthier,   cleaner   and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step   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.

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 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 close out and retrieval of trial materials.   Ensures that   required   crucial 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 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