FSP Clinical Trial Coordinator II

Thermo Fisher Scientific is hiring a FSP Clinical Trial Coordinator II to provide administrative and technical support for clinical trial project teams. The role supports audit readiness, site activation, regulatory documentation, study records and feasibility activities, while coordinating with investigators, site personnel and internal teams.

Responsibilities

According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix

Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s)

Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate

Performs administrative tasks on assigned trials including but not limited to

Timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members

Reviews and tracks local regulatory documents

Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation

Maintains vendor trackers

Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites

Assists with study-specific translation materials and translation QC upon request

Assists with technical and administrative support for projects in collaboration with internal departments and team members

Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided

Ensures that trial status information relating to activities is accurately maintained in the database and current at all times

Where applicable, develops and maintains relationship with client local affiliates

Champions the inclusion of Strategic Collaboration sites into the process

Where applicable, conducts on-site feasibility visits (Asia Pac only)

Trains new personnel in processes and systems

May support the maintenance of study specific documentation and global support with specific systems, tools and trackers, including, but not limited to, study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s)

May provide system support (i.e., Activate & eTMF)

May support RBM activities

May transmit documents to client and centralized IRB/IEC

May attend Kick off Meeting and take notes when required

May support scheduling of client and/or internal meetings

May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes

Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned

Assists the project team with the preparation of regulatory compliance review packages

May support start-up team in Regulatory submissions

Occasionally works directly with site(s) to obtain documents related to site selection

May develop site list, including research from internal and external sources to ensure the site list is reflective of the defined site profile. Ensure current investigator and site staff contact details are appropriately maintained in company systems

May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. Document in real time all communication, attempts and follow up associated with site contact and survey responses

Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked

Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks

Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalates concerns/non-compliance to management

May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites

May conduct phone interviews, scripted or non-scripted, with physicians and other site personnel to discuss standard of care and obtain protocol-level input to support trial optimization projects

Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information

Contributes to the development and roll-out of global strategic feasibility processes and best practices

Preferred

Bachelor's degree preferred

Company

Scientific technologies and biotech/pharmaceutical services

Waltham, Massachusetts, USA

https://www.thermofisher.com/

Founded in 1956

10001+ employees

Qualifications

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 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

Ability to work in a team or independently, as required

Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively

Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency

Strong customer focus

Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines

Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non clinical/clinical aspects of project implementation, execution and closeout

Excellent English language and grammar skills and proficient local language skills as needed

Good presentation skills

Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtainknowledge and master all clinical trial database systems

Self-motivated, positive attitude with effective strong interpersonal skills

Effective oral and written communication skills, with the ability to communicate effectively with medical personnel

Excellent interpersonal skills

Strong attention to detail and quality of documentation

Good negotiation skills

Good computer skills and the ability to learn appropriate software

Fluency in local language as well as a good command of the English language and grammar skills

Basic medical/therapeutic area and medical terminology knowledge

Ability to work in a team environment or independently, under direction, as required

Basic organizational and planning skills

Basic knowledge of local health systems

Ability to attain and maintain a working knowledge of GCP and applicable SOPs

Excellent customer focus

Proven flexibility and adaptability

Ability to work in a matrix environment

A proven relationship builder

An independent thinker

Ability to manage risk and perform risk escalation appropriately

Bachelor's degree preferred

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

Required skills

Clinical Trial Coordination, ICH Good Clinical Practice (GCP), Regulatory Compliance, Clinical Trial Master File (eTMF) Management, Clinical Trial Management Systems (CTMS), Microsoft Office, Clinical Trial Database Systems, Medical Terminology, Clinical Site Feasibility

Preferred skills

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Experience

2+ years