Clinical Trial Associate 2

GRIFOLS, S.A.

About The Position

Provides administrative/Clinical support on assigned projects/programs. Ensures that the project/program needs are met within timelines established. Key Responsibilities: Assists the clinical team in daily study operations which includes tracking of documents, special projects, distribution of safety reports, and preparing meeting minutes from internal project meetings. Coordinates meeting scheduling, draft meeting agendas/minutes, and assists in preparing PowerPoint slides as needed. Maintains project related trackers and provides this information to study manager. Files clinical trial documents for ongoing projects and assists in the archival of CRO study files and legacy documentation. Coordinates logistics of study related meetings including medical expert meetings, investigator meetings, and kick off meetings. Assists in project travel plans, reservations, and expense reports, specific to meetings wherein they were responsible for logistics. Maintains clinical trial management system (CTMS). Creates studies within the system per SOPs, tracks study specific data, and generate reports. Assists in the distribution of key clinical study documents such as investigator brochures, protocols, informed consents, and regulatory submissions. Receives, reviews, and tracks regulatory documents from clinical sites and CRO. Submits and tracks essential documents to the Trial Master File (TMF) on an ongoing basis. Assists in the preparation, quality review, and publishing/distribution of key clinical study documents such as informed consent documents, essential regulatory document requirements, study manuals, investigator brochures, protocols, clinical study reports, and regulatory submissions. Assists in the electronic filing of these approved documents. Obtains, tracks, and maintains, applicable CRO SOPs and subsequent revision versions throughout study. Coordinates the set up, filing, maintenance, and periodic review of TMF and project electronic filing system throughout the study. Assists with the development and maintenance of project timelines. Additional Responsibilities: Develops, implements, and maintains effective processes, tracking tools, and communication with internal and external customers to increase project and departmental efficiencies. Coordinates documentation, tracks and assists in the management of clinical study supply releases (i.e. study drug, ancillary supplies), ensures regulatory is provided with appropriate documentation of approved investigator sites which will allow centers to be opened. Reviews TMF and Clinical Development documents for completeness and accuracy throughout the project. Oversees progress of CRO in the collection of essential documents during study start-up. Develops essential regulatory document tracking requirements for CRO. Manages vendors and associated data. Manages vendor and site CDAs, contracts, and payments throughout the study. Follows up on study progress, and coordinate updates and/or retrieval of appropriate regulatory documents throughout the study. Managers and supervisors may assign other duties as needed

Requirements

Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned.
Excellent knowledge of ICH/GCP Guidelines and EDC process.
Excellent verbal and written communication skills.
Ability to train others in using MS Office Suite, Impact, and EDC systems.
Ability to meet deadlines, multitask, and prioritize based on study needs.
Ability to make sound decisions based on available information.
Ability to establish rapport with site personnel/ colleagues.
Ability to work both in a team and independently.
Ability to facilitate team meetings and teleconferences.
Ability to present at internal study team meeting (s).
Ability to train and mentor junior CTAs.
Ability to seek new learning opportunities within and outside of the assigned project.
Ability to travel (international and domestic) up 25%, depending on project needs.
Typically requires 4 years of experience as a clinical trial associate.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate’s degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree.

Responsibilities

Assists the clinical team in daily study operations which includes tracking of documents, special projects, distribution of safety reports, and preparing meeting minutes from internal project meetings.
Coordinates meeting scheduling, draft meeting agendas/minutes, and assists in preparing PowerPoint slides as needed.
Maintains project related trackers and provides this information to study manager.
Files clinical trial documents for ongoing projects and assists in the archival of CRO study files and legacy documentation.
Coordinates logistics of study related meetings including medical expert meetings, investigator meetings, and kick off meetings. Assists in project travel plans, reservations, and expense reports, specific to meetings wherein they were responsible for logistics.
Maintains clinical trial management system (CTMS). Creates studies within the system per SOPs, tracks study specific data, and generate reports.
Assists in the distribution of key clinical study documents such as investigator brochures, protocols, informed consents, and regulatory submissions.
Receives, reviews, and tracks regulatory documents from clinical sites and CRO.
Submits and tracks essential documents to the Trial Master File (TMF) on an ongoing basis.
Assists in the preparation, quality review, and publishing/distribution of key clinical study documents such as informed consent documents, essential regulatory document requirements, study manuals, investigator brochures, protocols, clinical study reports, and regulatory submissions. Assists in the electronic filing of these approved documents.
Obtains, tracks, and maintains, applicable CRO SOPs and subsequent revision versions throughout study.
Coordinates the set up, filing, maintenance, and periodic review of TMF and project electronic filing system throughout the study.
Assists with the development and maintenance of project timelines.
Develops, implements, and maintains effective processes, tracking tools, and communication with internal and external customers to increase project and departmental efficiencies.
Coordinates documentation, tracks and assists in the management of clinical study supply releases (i.e. study drug, ancillary supplies), ensures regulatory is provided with appropriate documentation of approved investigator sites which will allow centers to be opened.
Reviews TMF and Clinical Development documents for completeness and accuracy throughout the project.
Oversees progress of CRO in the collection of essential documents during study start-up.
Develops essential regulatory document tracking requirements for CRO.
Manages vendors and associated data. Manages vendor and site CDAs, contracts, and payments throughout the study. Follows up on study progress, and coordinate updates and/or retrieval of appropriate regulatory documents throughout the study.
Managers and supervisors may assign other duties as needed