Clinical Studies Spt Coord II - Integrated Resources, Inc

HM's Top 4:

1. Project Management,
2. Data Collection Definition
3. Data Quality Management
4. Data Continuity and Optimization.

Education Required: Bachelors Degree in Life sciences or Computer Science

Years’ Experience Required: 2-4 years

40 hours per week

Remote
The Clinical Data Specialist position is responsible for the life cycle of clinical data from collection to delivery for analysis. This includes ensuring the necessary data is being collected to meet study goals and achieving both data integrity (i.e., data is managed the right way) and data quality (i.e., data is credible and reliable).

This position requires the ability to demonstrate strong functional leadership over time through:
Delivering on commitments
Incorporating Quality by Design
Developing and maintaining strong partnerships
Staying current with industry trends through continuous learning
Acting as a data privacy steward
Developing strong Data Management expertise
Applying risk based decision making


Responsibilities may include the following and other duties may be assigned.
Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review.
Design and implement clinical protocols and data collection systems.
Develops systems for organizing data to analyze, identify and report data and trends.
Manages data management issues by reviewing protocols for cross-project consistency, and identifying standard Case Report Form (CRF) modules to meet objectives.
Develops data quality plans.
Provide early strategic input into protocol design focused on data management issues.
Review and resolve data discrepancies for standardized data validation systems and procedures.
Prepares reports of clinical trial studies for internal validation and cross validation studies.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, Product input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.

Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.