SUMMARY: The Site Document Specialist, under direct supervision, coordinates IRB and site related regulatory activities related to the clinical research trial.
Tasks may include but are not limited to:
Collects, reviews, processes and tracks required study-specific site regulatory documents (Form 1572, financial disclosure forms, protocol signature pages, etc.) from participating research sites in accordance with applicable SOPs and guidelines and Essential Document Review Plan. Quality checks documents and escalates as needed.
Translates study-specific site regulatory documents in accordance with WCT SOPs and/or Sponsor SOPs if applicable
Maintains list of outstanding study specific site regulatory documents by site and / or country and follow up with site or internal team members as needed
Maintains and updates relevant document information in the study modules and systems as assigned and applicable
Provides instruction to sponsor/CRO personnel on policies and procedures as related to central site regulatory documentation collection and maintenance.
Communicates with sponsor/CRO representative/ participating research site to discuss site regulatory documentation as it relates to issue resolution and documentation requirements.
Prepares study specific informed consent form utilizing the IRB approved template. Coordinates the translation of the informed consents forms, if applicable.
Collaborates with sponsor/CRO to adopt and implement protocol changes requested by IRB.
Ensures all site regulatory files are prepared for storage in accordance with SOP's and regulatory guidelines.
Submits protocols, amendments, informed consents, IDB, advertising materials, continuing reviews and protocol deviations/exceptions to the IRB.
Performs 1st review and where applicable and as assigned final/2nd review of Essential Document packages for IP Release to investigative sites
Prepares and submits hardcopies of site essential documents for storage at Central Records or Trial Master File
Performs other duties as assigned.
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
Excellent organizational, time management and customer service skills.
Good computer skills to include computer literacy with document and spreadsheet applications.
Ability to review and understand technical and medical documents
Knowledge and understanding of ICH, GCP and FDA as well as local regulatory requirements.
Excellent spoken and written English language skills.
High School diploma or equivalent required. Associate degree or equivalent preferred.
Knowledge of biopharmaceutical/CRO industry.
Experience in administrative support and/or clinical research to include a minimum of 1 year experience in site startup processes and document review.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility
Worldwide Clinical Trials - 18 months ago