KPS Life Looking for Clinical Research Associate (CRA) – Raleigh, NC at Remote Full Time

Job type contract

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Full job description

Kps life is seeking experienced cras based in north carolina! this will be dedicated to one sponsor partner working on ivd studies.
Job description
The clinical research associate (cra) is responsible for monitoring activities that will lead to successful execution of ivd clinical studiesThey will proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicableThe cra engages with internal and external stakeholders as a member of the outcomes & evidence clinical trial operations team.
Key responsibilities

Supports the clinical team in clinical monitoring and operational study execution of assigned protocol and sites.
Conducts all types of monitoring, co-monitoring, cra evaluations at study sites as required by the sponsor and sow.
Coordinates and attends cra teleconferences (weekly or as needed).
May assist in the design and development of study related documents including (but not limited to) monitoring guidelines, monitoring plans, cra evaluation plans, informed consent form (icf) templates, case report forms (crfs), crf guidelines/instructions data management plans, source document templates, monitoring visit report templates, site tools and worksheets
Assist in the study-start up review process and tracking of regulatory documents, and other study-related documents.
Creates, maintains, and reports metrics for monitoring study visit reports and study data.
Writes trip reports or evaluation reports and follow-up letters as required by sops for study visitsAlso responsible for the tracking of all study visits and reports and make sure they are consistent with the monitoring plan.
Interface with individuals in other functional areas to address study needs (i.e., quality).
May assist in the review of required documents for clinical trial material release authorization.
Performs data review, query generation and query resolution from respective system (i.e., ctms).
Participates in meetings and conference calls with internal project teams, sponsor teams, and external partners (i.e., cros).
May participate in the training of vendors, or cro staff, and study coordinators on study requirements.
May be required to train site staff on protocol specific issues, gcps or other necessary training.
Must ensure consistency with contract and travel policy.
Ability to travel up to 60% with an average of 10-12 days on site per month.

Education & experience

Bachelor’s degree or equivalent combination of education and experience.
Must have at least 3 years of field clinical monitoring experience with a cro or sponsor.
Strong problem solving, organizational and time management skillsAbility to multi-task and attend to detail.

Required skills

Excellent verbal, written communication skills and interpersonal and presentation skills are required (english).
Excellent keyboard skills, with experience using microsoft office (outlook, word, excel, and power point) applications to prepare charts, tables, forms, reports and presentations.
Experience with email and calendar programs required.
Ctms, etmf, and electronic data capture (edc) experience required.
Knowledge of fda and/or emea regulations, ich/gcp guidelines governing the conduct of clinical trials.
Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.
Off solutions when obstacles are identified and train as necessary to achieve project goals.
Must have a general understanding of routine project goals from an organizational perspective.
Strong organizational skills and attention to details required.
Ability to prioritize and plan workload is essential.

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