Clinical Trial Coordinator I

This is a fully remote position, open to applicants in Poland.

📋 Description

• Offer both administrative and technical assistance to the Project Team.

• Facilitate audit readiness by performing scheduled reviews of department, internal, country, and investigator files, and documenting findings in the appropriate systems.

• Organize, supervise, and complete assigned trial activities based on the task matrix.

• Ensure that designated tasks are finished punctually, within budget, and to a high-quality standard; communicate any risks to project leads.

• Provide system support for Activate and eTMF, ensuring system databases are up-to-date.

• Manage documentation for the Client eTMF, conduct eTMF reviews, distribute mass mailings and communications, and supply documents and reports to internal team members.

• Analyze and reconcile study metrics and findings reports; assist in addressing site-documentation findings.

• Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials along with non-clinical study supplies to sites.

• Assist with study-specific translation materials and oversee translation quality control.

• Maintain familiarity with SOPs, client directives, and regulatory guidelines.

• Conduct on-site feasibility assessments where applicable (Asia Pac only); occasional travel may be necessary.

• Facilitate scheduling of client/internal meetings and track local regulatory documents.

• Support RBM activities, study documentation, training requirements, system access, and project activity plans.

• Transmit documents to the client and centralized IRB/IEC.

• Maintain vendor trackers.

• Assist the start-up team with regulatory submissions.

• Collaborate directly with sites to obtain site-selection documents.

• Aid in preparing regulatory compliance review packages and coordinate with internal departments to align site start-up activities with the site-activation critical path.

• Complete Site Interest Plans in CTMS where applicable and gather associated investigator/site documents.

• Record site communications, follow-ups, and survey responses in real-time; review survey data for completeness and logical consistency.

• Work collaboratively with teammates and clinical personnel to meet deadlines and address site-related issues and risks.

• Ensure effective site-contact and follow-up plans, escalating concerns or non-compliance to management.

• Serve as a local expert on site capacity and experience, recommend additional sites, and assist in local site tiering.

• Collaborate with Global Investigator Services to resolve investigator inquiries and maintain account/contact information.

• Contribute to global strategic feasibility processes and best practices.

• Train new personnel in established processes and systems.

• Utilize local knowledge to identify and cultivate new sites.

⛳️ Requirements

• High/Secondary school diploma or equivalent along with relevant formal academic/vocational qualifications.

• Bachelor's degree is preferred.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (equivalent to 0 to 1 year).

• In some instances, an equivalency combining appropriate education, training, and/or directly related experience may be deemed sufficient for fulfilling the role's requirements.

• Capability to work both collaboratively in a team and independently as needed.

• Strong organizational skills and attention to detail, with a demonstrated ability to manage multiple tasks effectively and efficiently.

• Proven ability to analyze project-specific data/systems to ensure accuracy and efficiency.

• Strong customer service orientation.

• Flexibility to adjust workload priorities to accommodate changing project timelines.

• Working knowledge of relevant Country Regulations, ICH Good Clinical Practices, and organizational/Client SOPs and WPDs.

• Proficient English language and grammar skills, along with the necessary local language skills.

• Competent computer skills; proficient in MS Office (Word, Excel, and PowerPoint) and capable of learning clinical trial database systems.

• Ability to successfully complete the organization's clinical training program.

• Self-motivated with a positive attitude and strong interpersonal skills.

• Effective verbal and written communication capabilities.

• Essential judgment and decision-making skills.

• Competent in accurately following project work instructions.

• Strong negotiation skills.

• Independent thinker.

• Ability to manage risk and appropriately escalate risk issues.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and growth.

• Supportive and collaborative work environment.

• Flexible work arrangements.