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Job Title: FSP Clinical Trial Coordinator II
Job Location: Remote, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri) Environmental Conditions
Office Job Description
Join Us as a Clinical Trial Coordinator II – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Operations Delivery Associate II, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing the organization in the global medical research community, you may develop collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and within deliverable timelines. You may develop a local knowledge base of sites in the respective market through collaboratively working with local company personnel. Additionally, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. You may act as a buddy during the onboarding phase, support training of new staff, and participate in departmental initiatives to aid in process improvements and enhancements.
What You’ll Do:
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.
Education and Experience Requirements:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Bachelor's degree preferred.
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.
Knowledge, Skills and Abilities:
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
Ability to successfully complete the organizations clinical training program
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
Working Conditions and Environment:
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.
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