Clinical Trial Coordinator- Finance FSP
Clinical Trial Coordinator- Finance FSP
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
Parexel FSP is looking for a Clinical Trial Coordinator Finance.
This position is a hybrid position with 1day minimum onsite requirement in Kirkland Quebec. Experience in Site Payments and Budgets Required.
Job Title: Clinical Trial Coordinator (CTC)
Position Purpose: The Clinical Trial Coordinator (CTC) is responsible for the following:
Supports the Clinical Research Manager (CRM) and other team members through the life cycle of the study from study start up to study closure.
Organizational Relationships:
Reports to Parexel assigned Line Management with daytoday direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.
Primary Responsibilities:
Trial and site administration:
o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports).
o Ensure collation and distribution of study tools and documents.
o Update clinical trial databases (CTMS) and trackers.
o Clinical supply & nonclinical supply management in collaboration with other country roles.
o Manage Labeling requirements and coordinate/sign translation change request.
Document management:
o Prepare documents and correspondence.
o Collate distribute/ship and archive clinical documents.
o Assist with electronic Trial Master File (eTMF) reconciliation. o Updating manuals/documents (e.g. patient diaries instructions).
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders.
o Execute eTMF Quality Control Plan.
o Obtain translations of documents.
Regulatory & Site Start Up responsibilities:
o Provide to and collect from investigators forms/lists for site evaluation/validation site startup and submissions in a timely manner.
o Obtain track and update study insurance certificates.
o Support preparation of submission package for Institutional Review Board (IRB) / Ethics Review Committee (ERC) and support regulatory agencies submissions.
o Publish study results for Global Clinical Trial Operations (GCTO) and Regulatory Affairs (RA) where required per local legislation.
Budgeting Agreement and Payments: Collaborate with finance/budgeting representatives for:
o Development of country and site budgets (including Split site budget).
o Tracking and reporting of negotiations.
o Maintenance of tracking tools.
o Working knowledge of contract development negotiation approval and maintenance (e.g. Clinical Trial Research Agreements (CTRAs).
o Updating and maintenance of contract templates (in cooperation with Legal Department)
o Payment calculation and (investigators vendors grants
o Ensuring compliance with financial procedures.
o Monitoring and tracking adherence and disclosures.
o Budget closeout.
o Obtain and process Foreign Corrupt Practices Act (FCPA) documentation in a timely manner.
Meeting Planning:
o Organize meetings (create & track study memos/letters/protocols).
o Support local investigator meetings (invitations prepare materials select venue support where applicable).
Completes training assigned by Client and/or EP as necessary including general training requirements SOPs and system and process related training.
Adheres to EP and Client SOPs and processes.
Education and Certification:
B.A./B.S. (Life Sciences preferred) or equivalent healthcare experience.
Skills and Experience:
Minimum 12 years in Clinical Research or relevant healthcare experience. Note Specific experience requirements may vary depending on the Country
Good understanding of Global Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices.
Good IT skills (Use of MS office use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
International Committee on Harmonization (ICH) Good Clinical Practice (GCP) knowledge appropriate to role.
Effective time management organizational and interpersonal skills conflict management.
Effective communication with external customers (e.g. sites and investigators).
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus.
Able to work independently.
Proactive attitude to solving problems / proposing solutions.
Positive mindset growth mindset capable of working independently with assigned tasks.
Contributes to CTC team knowledge by acting as buddy /mentor and sharing best practices as appropriate/required.
Language Skills:
Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
#LISS1
Required Experience:
IC
Employment Type
Full Time
