Summary:

Assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.

Primary Responsibilities:

• Tracks study specific tasks and progress of the trial.
• Performs regulatory document review and approval for IP release.
• Assists in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings).
• Conducts monitor training.
• Performs monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.
• Understands and implements processes for distribution and tracking of SAE’s, safety documentation, and pregnancies. Monitors compliance of these processes.
• Collaborates with data management to resolve queries.
• Facilitates investigator site payments, as applicable.
• Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.
• Assists in evaluation of vendor performance during conduct of the study.
• Acquires a basic knowledge of the therapeutic area and product.
• Obtains a complete understanding of all trial-related documents and operational procedures.
• Gains exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes.
• Maintains clinical trial management system (CTMS) information pertaining to the study.
• Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
• Reviews and tracks study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
• Prepares accurate and complete meeting minutes for various meetings.
• Communicates and interacts with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.
• Assists with effective and timely audit/inspection responses.

For studies monitored in house by Grifols, additional responsibilities may include:

• Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
• Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
• Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance.
• Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
• Reconciles clinical supplies and drug accountability records at study sites.
• Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
• Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
• Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities.

Additional responsibilities:

Assists in the development of study timelines and ensures compliance. Assists in the management of vendors. Prepares key reports and documents on progress of study for study manager. Monitors adherence to the regulatory document collection process. Interacts with data management, safety, regulatory personnel, and other functional groups. Assists team members in reviewing data listings and writing queries. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Reviews study specific ICF(s) for compliance with ICH/GCP and company SOPs. Participates in CRF development and completion.

Knowledge, Skills, and Abilities:

Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Good knowledge of therapeutic area assigned. Strong knowledge of ICH/GCP Guidelines and EDC process. Strong 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 CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel.

Requirements:

Associate’s degree in a life science field required. Bachelor’s degree in a life science field preferred.

Typically requires 2 years of experience in clinical research, including a minimum of 1 year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).

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 requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

EEO Minorities/Disabled/Veterans/Women

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