ADMINISTRATOR GLOBAL DATA MANAGEMENT at K2 Staffing LLC – Lady Lake, Florida

K2 seeking an experienced Data Entry Specialist to support our clinic out of The Villages, FL. This position will promote good clinical practices in the conduct of clinical investigations by possessing an in-depth knowledge of federal regulations and K2 Medical Research guidelines (SOPs) for the enrollment and maintenance of subjects in clinical trials, and by collecting, recording, and maintaining source and sponsor documentation.

Primary Responsibilities:

• This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g., nurses, patient care coordinators, insurance companies), and patients. Up to 10 projects will be in progress simultaneously, with the expectation ofadditionalprojects in the future.
• With minimal guidance, implement research project procedures that meet research objectives and ensure compliance with all aspects of the Institution, the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g., investigator financial disclosure requirements of the FDA)
• Develop,documentandmaintainprocedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
• Work with clinical research staff to design, create and revise research instruments (e.g., case report forms) as necessary to ensure quality data that satisfies researchobjectives.
• Prompt completion of electronic data capture systems and electronic case report forms. Timely resolution of queries and questions from industry sponsors, contract researchorganizationsand Institutional Review Board.
• Work with Regulatory Coordinator to ensure that reports to the Institutional Review Board and study sponsors aretimely,accurateand satisfy applicable regulation. With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity.
• Work collaboratively with research team to ensure that projects are executed successfully and completed within requiredtime framesto meet researchobjectives.
• Prepare interim reports for principal investigators, industrysponsorsand Institutional Review Boards to ensure that each project is moving towardtimelycompletion.
• Gather metrics on current EDC/QC processes including but not limited to:
• Current delegation of workload and percentage of work done of data entry team, including, but not limited to:
• Number of study subject binders/visitsentered intovarious data systems
• Number of queries resolved within a week’s period per data manager.
• Investigation and root cause analysis of current data process issues and the development of tracking/metrics-gathering systems to ensure company prescribed protocols are being met.
• Facilitation of study startups in obtaining and distributing of information specific to data processes and procedures, including but not limited to:
• Attendance at Study Initiation Visits to garner and distribute pertinent information on specific studies to all personnel associated with study.  This information is including but not limited to:
• Which data system will be used for the capture of study data.
• The obtaining of early study access and/or screenshots for system readiness.
• Specific information needing to be entered for Screen Fails.
• Requests for EDC eCRF guidelines to ensure system readiness.
• Access Requests for Data Entry Team via various lines of communication to ensure full access at study start up.
• Initiation and maintenance of new logsdeemedappropriate bymanagement tofacilitatecommunication and book accountability.
• Facilitation of meetings between EDC/QC and Source/Coordinatorsregardingspecific issues with study protocol adherence. 
• Compilation of weekly report including all metrics gathered within week, providing a snapshot of the progress on current process improvement initiatives.
• Providing query reports toassistin query resolution
• Answering queries
• Maintaining organized and accessible documentation of violations to current Compass Research protocol/GCP.
• Maintaining organized and accessible documentation of all reports from initiation of process improvement initiative.  
• Strict adherence to all study protocols to which employee has been granted access.
• QC Study Subject Binders on regular basis Responsibilities for this including but not limited to:
• Ensures adherence to Compass policies and SOPs.
• Performs Compliance reviews on informed consent process documentation.
• Performs compliance review to ensure accuracy of inclusion/exclusion criteria to confirm Subject’s eligibility.
• Performs compliance reviews on staff performance as it relates to adherence to protocol screening and randomization requirements and associated documentation
• Performs routine and/or random compliance checks on overall study performance as directed.
• Other duties as assigned

Knowledge, Skills, Abilities:

• Excellent interpersonal and communication skills (written and oral)
• Ability to multi-task
• Strong planning and organizational skills
• Strongproblem solvingskills
• Strong understanding of Root Cause Analysis
• Detail-oriented
• Takes initiative
• Team player
• Ability to adapt and work in a fast paced and changing environment
• Extensive software and internet research skills
• Proficient withvarious typesof office equipment, web-based software, MS Office.
• Strong skills with Microsoft Office and Excel
• Sensitivity to confidential matters

Qualifications:

• Minimum ofAssociatesDegreeisrequired.
• Experience in Quality Control

At K2, we value our employees and their professional and personal needs, and support these through our benefit offerings:

• Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
• 401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
• PTO of 16 days per year, 17 days after the first year of FT employment
• 9 paid Holidays
• K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.

Join the K2 Family: Where Compassion and Connection Lead the Way! At K2 Med, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff. We thrive on empathy, a patient-first approach, and absolutely zero big egos (unless it's an ego about being extra kind, then we'll allow it!). We believe a supportive, caring experience is paramount for our patients, and that starts with you.

We celebrate what makes you uniquely you! Your race, color, religion, marital status, age, national origin, or even your favorite snack (though we're partial to good research snacks) don't define your talent or fit here. If you need a little extra support or accommodation due to a disability, no sweat! Just reach out to our friendly team at Talent@k2med.com, and we'll ensure you have everything you need to shine.