FSP Clinical Trial Coordinator

Lifelancer is a talent-hiring platform serving the life sciences, pharmaceutical, healthcare, health technology, and IT sectors. The Clinical Trial Coordinator provides administrative and technical support to project teams, supporting audit readiness, site activation, feasibility activities, regulatory submissions, documentation management, and clinical trial systems. The role also coordinates site communications, tracks study metrics and vendors, and supports training and process improvements.

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

Provides system support (i.e., Activate & eTMF) and ensures system databases are always current

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

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

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

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

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

May support scheduling of client and/or internal meetings

May review and track of local regulatory documents

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

May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s)

Transmits documents to client and centralized IRB/IEC

Maintains vendor trackers

Supports start-up team in Regulatory submissions

Works directly with sites to obtain documents related to site selection

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

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

May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel

Documents in real time all communication, attempts an 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 escalate 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. Harness this knowledge base when performing local tiering of sites

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

Trains new personnel in processes and systems

Utilizes local knowledge to contribute to the identification and development of new sites

Preferred

Bachelor's degree preferred

Benefits

Remote work arrangement

Company

AI-powered talent hiring platform for life sciences, pharma, and IT

London, England, GBR

https://lifelancer.com/

Founded in 2020

11-50 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 0 to 1 year)

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

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

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

Strong customer focus

Flexibility to reprioritize workload 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

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

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

Ability to successfully complete the organizations clinical training program

Self-motivated, positive attitude and good interpersonal skills

Effective oral and written communication skills

Good interpersonal skills

Essential judgment and decision-making skills

Capable of accurately following project work instructions

Good negotiation skills

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 0 to 1 year).

Required skills

ICH Good Clinical Practice (GCP), Clinical Trial Management Systems (CTMS), Microsoft Office, Country Regulatory Requirements, Standard Operating Procedures (SOPs)

Preferred skills

Bachelor's degree preferred

Experience

Entry level