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.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and complete high-quality, cost-efficient clinical studies.

Position Overview:

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.

Essential Functions:

Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned.
Completes and documents study-specific training.
Orients and trains on any CRG/study-specific systems.
Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
Supports to customize Site ICF with site contact details, as needed.
Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
Verifies document collection and RCR submission status; updates site EDL and verifies site information.
Reviews patient facing materials and review translations, as directed.
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 directed.
Supports maintenance of vendor trackers, as directed.
Coordinates study/site supply management during pre-activation and subsequent course of the study.
Supports Essential 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 directed.
Supports ongoing remote review of centralized monitoring tools, as directed.
Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed 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 directed.
May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix.
May perform a specific role profile for FSP opportunities according to Client requests.
Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.

Keys to Success:

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 to 2 years).

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 to attain and maintain a working knowledge of ICH GCP, applicable regulations and CRG procedural documents
Effective oral and written communication skills
Excellent interpersonal and customer service skills
Good organizational and time management skills and strong attention to detail, with tried ability to handle multiple tasks efficiently and effectively
Proven flexibility and adaptability
Ability to work in a team or independently, as required
Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
Advanced 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

What we offer:

We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD® clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

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.

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