The Clinical Project Specialist II (CPS II) is responsible for the day-to-day overall implementation and operation of clinical studies with the guidance of a Clinical Project Manager (CPM) or Senior CPM (Sr. CPM) to ensure compliance with Good Clinical Practices, SOPs and other applicable regulations. The CPS II leads and collaborates with both internal stakeholders and external vendors to oversee execution and proper document compliance for critical tasks associated with the planning and conduct of clinical studies. Additionally, the CPS II plays a lead role in development for workflow and processes within the department and in improvement of processes through tool/template development and review/authorship of processes.
Proposal, contracting and funding:
- Assists in the preparation, publication and submission of proposals for government or internal funding.
- Reviews and provides advice for contracts related to study services.
Key study document writing and support:
- Leads study team to collaborate with Clinical Research Organization (CRO) under guidance from the Clinical Project Manager (CPM or Senior CPM) to define, generate and review the study specific procedures, study folders, protocol, informed consent form (ICF) / HIPAA authorization template, case report forms (CRFs), data management plan, monitoring plan, laboratory manual, pharmacy manual, study supplies and all other applicable study documents.
- Responsible for formatting, preparation and management of study documents for distribution, review, publication and version control, where applicable.
- Creates, revises, and archives internal forms and reports in template format.
- Verifies and ensure completeness of appendices for the Clinical Study Report (CSR).
Project planning, conduct, and closeout:
- Oversees collection and submission of regulatory/ethics documents.
- Contributes to the review of clinical data throughout the study as described in study plans; collaborates with study team to compile review reports for further follow-up.
- Leads management of investigational medical product (IMP) and study supplies; this includes including liaising with internal groups to ensure appropriate documentation is completed and workflows for IMP procurement, release, and shipment are maintained.
- Oversees reconciliation of invoices from clinical study sites, committee members and/or consultants.
- Responds to site and vendor queries regarding study conduct (e.g., IMP shipments, laboratory supplies, site queries, and others). Escalates individual issues, as appropriate.
- Primary liaison with external department representatives responsible for maintaining Study Master File (TMF) documentation outside of clinical files (eg. Regulatory Affairs, Quality Assurance (QA), Non-Clinical, Assay Development).
- Leads follow-up with site and study team to complete reporting and documentation of serious adverse events (SAEs).
- Provides support to clinical study sites in the event of regulatory inspection, including provision of study documentation, compilation of inspection preparatory packages.
- Collaborates with sites/CROs to ensure completion of action items or key findings identified during audits or inspections.
- Reviews data management queries for completeness and accuracy and review of data listings, with generation of queries prior to database lock.
For outsourced clinical studies:
- Oversees the review of monitoring reports, ensuring thoroughness and accuracy. When delegated, ensures all outstanding action items identified during the monitoring visits are resolved. May conduct co-monitoring visits at the beginning, middle and end of the study, where applicable.
- Leads clinical study team to ensure the maintenance and integrity of TMF files for clinical study during in-life cycle in accordance with study plans, ie. oversees/receives clinical documents from external vendors, reviews for accuracy and ensures all queries are resolved prior to inclusion in the TMF.
- Oversees final TMF reconciliation following receipt from CRO and verifies completeness for archival. Collaborates with QA with oversight from the CPM or Sr. CPM, to finalize the TMF for final archiving at the end of the study.
For internally executed clinical studies:
- Collaborates with CPM (or Sr. CPM) to define parameters of the TMF according to study specific requirements based on existing SOPs and templates.
- Oversees the paper or electronic TMF including collection, filing, cataloging and tracking of all essential documents required to conduct a clinical study.
- Oversees or participate in remote monitoring of clinical study sites as required by monitoring plan to assure collection of accurate and complete clinical data, verification of source documents, collection of regulatory/ethics documents, adequate maintenance of Investigator files, and ensures compliance with the study protocol, regulatory requirements and GCP. Ensures all outstanding action items identified during the monitoring visits are resolved.
- Performs quality check of paper files for project and study-related documents to ensure their integrity and security and saves essential documents for the electronic TMF (e-TMF) within the clinical server system.
- Manages maintenance of the electronic correspondence system for specified clinical study.
- Maintains system for procurement of clinical study insurance through Legal and Corporate Compliance.
- Manages back up clinical study sample inventory with external vendors.
- Manages significant parts within a project, or across projects, at the discretion of the CPM or Sr. CPM.
- Generates and/or manages tools, forms and templates that will allow for implementation of study and/or company/department initiatives.
- Orients or mentors Clinical Study Associate(s) and Clinical Project Specialist(s).
- Leads and supervises a department initiative for improvement processes within the department and other workflow processes.
- Assists CPM or Sr. CPM with setting study meetings and manage agendas and minutes as well as communication internal and external to the organization. Assists with investigator meetings or hosting of vendors.
- Qualified candidates will have a Bachelor's degree in Life Science (consideration will be given to candidates without a degree but with substantial experience in the field).
- Minimum 5 years relevant clinical research experience in health sciences or pharmaceutical setting; 2 years of monitoring experience preferred.
- Computer literate with well-developed skills in the use of Microsoft suite of programs (Word, Excel, PowerPoint, Visio, and Outlook).
KNOWLEDGE, SKILLS & ABILITIES:
- Solid understanding of FDA / Health Canada or EMA regulatory requirements, and ICH GCP and CFR regulations as applicable to the job being performed.
- Able to evaluate work performed against Scope of Work (SOW) documentation and lead portion of study tasks with clinical manager oversight.
- Excellent oral and written communication skills required with the ability to effectively understand and present information, and deal confidently with internal and external stakeholders.
- Initiative, excellent attention to detail, with highly-developed organizational, and time-management skills are required.
- Flexible with the ability to prioritize tasks and multiple projects on an ongoing basis, and adapt easily to quickly changing situations.
- Self-starter with the ability to work both independently and as part of a multidisciplinary team.
- Anticipates and proactively identifies, recommend creative solutions or escalate issues for project resolution.
- Ability to lead appropriate changes and apply lessons learned from one project to the next.