Who We Are
Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. With our mission of Bringing clinical trials to life TM , we provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.
The Clinical Project Specialist is responsible for providing administrative and trial support to clinical projects thereby contributing to the cost efficiency and overall management of clinical trials in accordance with the standards of ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs). *Please note, this role has the potential to be hired at the Senior CPS level depending upon individual experience.
Specific tasks would include:
- Interfaces with Client representatives and Synteract project team.
- Assists project teams with selective aspects of trial management from startup to close-out on one or more projects.
- Provides support in creating the Trial Master File (TMF) and/or Investigator site files; assists with maintenance tasks such as tracking and filing for the duration of the project, and with preparation for audits and archiving.
- Provides support with set-up, access requests, and maintenance for project systems (e.g. AX, CTMS, EDC, Shared Drive).
- Maintains and updates project-related data in an existing database, (e.g. CTMS, DMS) contacting internal team members to gather information.
- Assists with the preparation and distribution of project-related correspondence (e.g. agendas, meeting minutes, tracking spreadsheets, newsletters and presentations).
- Assists with the adaptation of Informed Consent Form templates at site level, dependent on regional variances.
- Assists with the development of and updates to projects-related plans and site manuals
- Acts as primary in-house contact for site and CRA support in the receipt, collection, and tracking review of essential and non-essential documents and distribution of study-related communications.
- Reviews essential and non-essential documents from sites to ensure all required documents are accurate and complete.
- Compiles project-related packages (e.g. for IP release, regulatory submission).
- Assists with implementation of protocol amendments.
- Assists with potential site identification and facilitates site outreach activities for feasibility projects (e.g. CDA execution, Feasibility Questionnaire completion by site).
- Administers, reports and reconciles site payments.
- Develops Investigator Grants.
- Supports contract and budget negotiations with sites.
- Coordinates translation of project documents acting as primary contact with translation vendor.
- Assists with the planning, organization and execution of meetings (e.g. project Kick Off meetings, internal team meetings, Client meetings).
- Assists with the ongoing management of the TMF ensuring documents are filed appropriately, performs TMF file reviews and reconciliation, creates and tracks TMF action items/findings, and escalates overdue action items, as required.
- Assists with maintaining of project team lists.
- With PM oversight, leads periodic and ongoing review, management and QC of project specific training records, reporting any missing records to the PM and functional project leads as appropriate. Assists in obtaining training documentation from project team members.
- Support project related vendor management activities.
- Executes and distributes reports from various systems (e.g. TMF, CDMS, CTMS, Financial systems, etc.).
- Assists the PM with budget management including tracking out of scope items, performing timesheet or billing approvals in the system, following-up on billing queries and updating the system.
- Provide other project support to functional teams as directed by Line Management.
- Serve as mentor to Clinical Project Associates, as requested.
May also include:
- Act as Subject Matter Expert for designated clinical system or task, as assigned.
- Participated in department initiatives focused on process improvement, as assigned.
- Degree in a related field of study and a minimum of 5 years applicable industry experience or equivalent combination of education and experience.
- Working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Effective verbal and writing skills; English + local language, if relevant.
This job excludes Colorado applicants.
If you’re passionate about bringing clinical trials to life, we encourage you to apply today!
Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.