Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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 remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.
Key responsibilities:
Completes study and site management activities as defined in task matrix, and as applicable and advised for study assigned.
Completes and documents study-specific training.
Supports site staff with the vendor related qualification process, where applicable.
Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
Provides support to follow-up on site staff training, as applicable.
Coordinates and supports logistics for IM attendance, as advised.
Supports maintenance of vendor trackers, as advised.
Coordinates study/site supply management during pre-activation and subsequent course of the study.
Supports Crucial Document collection, review and updating in systems, as applicable.
Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as advised.
Supports ongoing remote review of centralized monitoring tools, as advised.
Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as advised and follows-up on site invoices throughout the study period.
Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as advised.
May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Keys to Success
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 to 2 years).
Knowledge, Skills and Abilities:
Basic medical/therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain a solid understanding of ICH GCP, applicable regulations and CRG procedural documents
Effective oral and written communication skills
Excellent interpersonal and customer service skills
Good interpersonal and time management skills and strong attention to detail, with proven track record to handle multiple tasks efficiently and optimally
Proven flexibility and adaptability
Ability to work in a team or independently, as the need arises
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Proficient digital literacy with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
Excellent English language and grammar skills
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make 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 - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
