FSP Clinical Trial Coordinator II

Overview

Provide administrative and technical support to the project team on clinical trials, covering audit readiness, site activation, feasibility assessments and site list development.

What you'll do

• Coordinate, oversee and complete functions on assigned trial activities as detailed on the task matrix, according to the specific role (Central or Local).
• Perform department, internal, country and investigator file reviews as assigned and document findings in appropriate systems.
• Ensure allocated tasks are performed on time, within budget and to a high quality standard, and proactively communicate risks to project leads and line manager.
• Perform administrative tasks on assigned trials, including timely processing of documents sent to client (e)TMF, performing (e)TMF reviews, distributing mass mailings and communications, and providing documents and reports to internal team members.
• Review and track local regulatory documents.
• Analyze and reconcile study metrics and findings reports, and assist with clarification and resolution of findings related to site documentation.
• Maintain vendor trackers.
• Assist with coordination, compilation and distribution of Investigator Site File (ISF) and pharmacy binder materials and non-clinical study supplies to sites.
• Assist with study-specific translation materials and translation QC upon request.
• Assist with technical and administrative support for projects in collaboration with internal departments and team members.
• Maintain knowledge of and understand SOPs, client SOPs/directives, and current regulatory guidelines applicable to services provided.
• Ensure trial status information is accurately maintained in the database and current at all times.
• Where applicable, develop and maintain relationships with client local affiliates.
• Champion the inclusion of Strategic Collaboration sites into the process.
• Where applicable, conduct on-site feasibility visits (Asia Pac only).
• Train new personnel in processes and systems.
• May support maintenance of study-specific documentation and global support with specific systems, tools and trackers, including study team lists, project-specific training tracking, system access management, and project-level activity plans.
• Ensure (e)TMF is up to date by following file review schedules and documenting findings in appropriate systems.
• May provide system support (e.g., Activate and eTMF), support RBM activities, and transmit documents to client and centralized IRB/IEC.
• May attend kick-off meetings and take notes, and support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• Provide support to coordinate with internal departments and align site start-up activities within the site activation critical path.
• Assist the project team with preparing regulatory compliance review packages and may support the start-up team with regulatory submissions.
• Occasionally work directly with sites to obtain documents related to site selection.
• May develop site lists, including research from internal and external sources, reflective of the defined site profile, and keep investigator and site staff contact details current in company systems.
• May complete the 'Site Interest Plan' in CTMS, collect and deliver associated documents, and document in real time all site communication, attempts and follow-ups.
• Support the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• Work in collaboration with teammates to achieve targeted deadlines, and communicate site issues and risks with the team and appropriate clinical personnel.
• Ensure an efficient, effective plan is in place for site contact and follow-up, comply with it, and escalate concerns or non-compliance to management.
• May act as the local expert regarding site capacity and experience, and harness this knowledge 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.
• Liaise with Global Investigator Services to resolve investigator queries in real time and maintain 'accounts and contact' information.
• Contribute to the development and roll-out of global strategic feasibility processes and best practices.

What you'll need

• High school / secondary school diploma or equivalent, and relevant formal academic or vocational qualification.
• Previous experience comparable to at least 2 years that provides the knowledge, skills and abilities to perform the job (an equivalency of education, training and/or directly related experience may be considered).
• 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 and systems to ensure accuracy and efficiency.
• Demonstrated ability to attain and maintain a good working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.
• Excellent English language and grammar skills, and proficient local language skills as needed.
• Excellent computer skills, proficient in MS Office (Word, Excel, PowerPoint), with ability to learn and master all clinical trial database systems.
• Ability to successfully complete the organization's clinical training program.
• Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.
• Strong attention to detail and quality of documentation.
• Basic medical/therapeutic area and medical terminology knowledge.
• Basic knowledge of local health systems.
• Ability to attain and maintain a working knowledge of GCP and applicable SOPs.
• Ability to work in a team or independently, as required, and in a matrix environment.
• Ability to manage risk and perform risk escalation appropriately.

Nice to have

• Bachelor's degree.
• Good presentation and negotiation skills.

Details

• Location: Remote, North Carolina, USA.
• Work schedule: Standard (Mon-Fri).
• Work is performed in an office, laboratory, clinical and/or home office environment, with exposure to electrical office equipment.
• Occasional drives to site locations; potential occasional travel required.