Clinical Trial Coordinator II - FSP

About the job

Work Schedule

Standard (MonFri)

Environmental Conditions

Office

Summarized Purpose:

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organizations SOP and department guidance document. Provides administrative support for site activation activities. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. Represents CRG personnel. 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. May act as a buddy during onboarding phase and provide training to new staff as needed.

Essential Functions

• 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 high1quality 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 nonclinical study supplies to sites.
• Assists with studyspecific 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 onsite 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 startup 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 starttup 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/noncompliance 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 rollout 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.

Knowledge Skills and Abilities:

• Bachelors Degree in Life Science is preferred
• Should have 25 years of experience in CRC or CTC role
• Should have excellent Business communication skills
• Should have good knowledge on eTMF and ICH GCP related activities
• Should be able to join us immediately
• Preferably from Mumbai and near by locations
• 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 projectspecific 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 non1clinical/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
• Selfmotivated positive attitude and good interpersonal skills
• Effective oral and written communication skills
• Good interpersonal skills
• Essential judgment and decisionmaking skills
• Capable of accurately following project work instructions
• Good negotiation skills
• Independent thinker
• Ability to manage risk and perform risk escalation appropriately

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Remote Work :

No