Grifols Shared Services North America, Inc Clinical Research Associate III in RTP, North Carolina
Grifols is currently seeking a Clinical Research Associate with Lead CRA experience. This candidate will 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. This candidate will ensure coordination of an accelerated study start-up including vendor set-up and oversite, pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. The Candidate should also have experience with the creation of monitoring plans, study specific tools, and experience with managing CRAs.
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.
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.
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.
Level 3- Bachelor's degree in a life science field required. Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years years in lead CRA role.
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.
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
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Req ID: 167927