Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Coordinator – 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 Trial Coord, 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 CRG personnel, 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. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed.

What You’ll Do:
•\tAccording to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
•\tPerforms department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
•\tEnsures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
•\tProvides system support (i.e., Activate & eTMF) and ensures system databases are always current.
•\tPerforms 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.
•\tAnalyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
•\tAssists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
•\tAssists with study-specific translation materials and translation QC upon request.
•\tMaintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
•\tWhere applicable, conducts on-site feasibility visits (Asia Pac only).
•\tMay support scheduling of client and/or internal meetings.
•\tMay review and track of local regulatory documents.
•\tMay provide system support (i.e., Activate & eTMF). May support RBM activities.
•\tMay 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).
•\tTransmits documents to client and centralized IRB/IEC.
•\tMaintains vendor trackers.
•\tSupports start-up team in Regulatory submissions.
•\tWorks directly with sites to obtain documents related to site selection.
•\tAssists the project team with the preparation of regulatory compliance review packages.
•\tProvides support as needed to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned.
•\tMay complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel.
•\tDocuments in real time all communication, attempts an follow up associated with site contact and survey responses.
•\tSupports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
•\tWorks in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
•\tEnsures 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.
•\tMay 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.
•\tLiaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.
•\tContributes to the development and roll-out of global strategic feasibility processes and best practices.
•\tTrains new personnel in processes and systems.
•\tUtilizes local knowledge to contribute to the identification and development of new sites.

Education and Experience Requirements:
•\tHigh / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
•\tBachelor's degree preferred.
•\tPrevious 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.

Knowledge, Skills and Abilities:
•\tAbility to work in a team or independently as required
•\tGood organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
•\tDemonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
•\tStrong customer focus
•\tFlexibility to reprioritize workload to meet changing project timelines
•\tDemonstrated 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
•\tGood English language and grammar skills and proficient local language skills as needed
•\tGood computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
•\tAbility to successfully complete the organizations clinical training program
•\tSelf-motivated, positive attitude and good interpersonal skills
•\tEffective oral and written communication skills
•\tGood interpersonal skills
•\tEssential judgment and decision-making skills
•\tCapable of accurately following project work instructions
•\tGood negotiation skills
•\tIndependent thinker
•\tAbility to manage risk and perform risk escalation appropriately



Working Conditions and Environment:
•\tWork is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment.
•\tOccasional drives to site locations. Potential Occasional travel required.