Clinical Research Nurse Coordinator managing clinical research operations at Duke's Trauma, Acute & Critical Care Division. Supervising nursing care and ensuring accuracy in data management.
About the role
- Clinical Scientist performing medical and scientific data review for haematology clinical trials at Syneos Health. Supporting lead scientists and managing project scopes to ensure deliverables.
Responsibilities
- Perform medical and scientific data review on haematology clinical trials (indication anticipated myeloma or lymphoma)
- Standard data listing review (data listings, AEs, con meds, etc.)
- May complete patient profile review, standard listing data review, efficacy review and safety narrative review, PD analysis and PD review
- Will support Lead Scientist with scientific data review of clinical trial
- May support with additional CS tasks beyond scope of data review at the discretion of the Lead CS team however the primary role will be scientific data review
- Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan)
- Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans
- Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews
- Authors medical data queries and reviews query responses, approves query closure in association with Medical Director
- May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed
- Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed
- Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met
- Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review
- Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety
- Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner
- Attends at Trusted Process meetings and may participate in internal and external audits
- Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology
- Adheres to all data privacy guidelines, ICH, and GCPs, all enterprise policies, standard operating procedures, work instructions, and project plans
- Adheres to customer policies and standard operating procedures, as required in project plans
Requirements
- Degree in life sciences (MSc, PharmD, PhD, DMD, MD) or equivalent with relevant scientific experience and/or training discipline
- Excellent time management skills to handle multiple tasks and meet deadlines while delivering high quality work in a highly regulated and dynamic environment
- A self-starter and comfortable with fluctuating timelines, work demands and changes in scope of work
- Ability to troubleshoot situations as needed and understands when issues or questions need to be escalated to the leadership
- Understanding of scientific principles to assure effective and high-quality medical data analysis
- Excellent written and oral communication skills
- Excellent computer skills: MS Office programs, spread sheets, presentations
- Prefer knowledge of drug development and demonstrated proficiency with ICH/GCP guidelines
- Strong team player with excellent interpersonal skills and ability to work effectively in a cross-functional team environment.
Benefits
- career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- Total Self culture
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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