Entry Level Clinical Research Specialist Jobs

Provides data entry and management support to an assigned caseload of research protocols

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

Reviews study protocols and assists in the planning and implementation of the data management aspects of clinical research projects

Possession of a Bachelor's degree from an accredited college/university, or qualifying experience in lieu of required education

Cloud–based clinical data management systems (e.g., Medidata Rave) and enrollment tracking systems (e.g., OPEN)

Works collaboratively with VRS team members, site staff, and data monitors to meet program and protocol requirements, deadlines, and deliverables

2+ years experience with a documentation for regulatory compliance of medical devices, clinical research, project management preferred

All training related to the quality management system is done in accordance to the Training Management Process.

Medical writer qualifications or Certified Research Associate a plus

Experience with both qualitative and quantitative research a plus

Strong collaborative and teamwork skills

We provide a flexible work environment to offer work/life balance

1-2 years of Upstream Biopharmaceutical Manufacturing experience

Prepare buffers for AAV manufacturing

Hands-on manufacture of AAV vectors

B.S/M.S in Virology, Cell Biology, Molecular Biology, Biochemistry, Chemical Engineering, or a related discipline

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

• Demonstrated experience in establishing and maintaining effective relationships with management, peers and subordinates and customers.

5) What are the top 5 skills/requirements this person is required have?

• Manage and prioritize work load, multi-task and manage a diverse mix of issues, responsibilities and challenges.

a. Required Skill 1: Organized and great attention to detail

b. Required Skill 2: Strong communication skills and intrapersonal skills

c. Required Skill 3: Takes initiative and works well alone and also within a team

Experience with Clinical Trials Management System (i.e., OnCore, Velos, etc.)

Organize and manage time and tasks independently

2 years of health care operations experience preferably in clinical research

Demonstrated skills in critical thinking and problem solving

Strong written and verbal communication skills

2 years of clinical research experience

Interacting professionally with managers, third-party service providers, and research team members to gather, enter, and analyze data.

Reviewing and extracting relevant information from manager presentations, due diligence questionnaires, private placement memorandums, and external databases.

Creating and running manager searches

Bachelor’s degree in Finance or business-related field (preferred but not required)

One-to-two years of investment experience

Experience using systems such as Morningstar, eVestment, Quickbase, Tableau, InvestmentMetrics, FactSet, and/or Bloomberg preferred

Experience in site monitoring/central monitoring skills, site qualification, and site training

Data management experience or analytics

Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution

3 years of previous experience with regulatory documentation for clinical studies, required

Experience in cardiac clinical research

Sponsor industry experience with clinical trial operations/research

Roles typically require a university degree or an extensive amount of practical knowledge gained through experience.

Must have knowledge in reference to good clinical practices regulations and standard operating procedures.

The job requires the ability to make judgements based on practice and previous experience.

Preferred, experience with electronic file system, Medidata and SharePoint & Smartsheet.

Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives.

Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings.

Organized - can prioritize and manage a variety of tasks and details without sacrificing service, accuracy, and efficiency

You enjoy working with our fun, supportive, and patient-centered staff while learning important industry skills!

Paid time off (PTO) for both full- and part-time employees

Medical that is available to everyone

Positive - approaches situations with enthusiasm and optimism

Excellent communicator - communicates with clarity to ensure nothing gets lost in translation

Previous study coordination and/or project management experience in clinical research

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

Knowledge of regulatory requirements and guidelines for facilitating clinical human subjects research, including Health and Human Services (HHS) regulations

Serves as the point-of-contact and project manager for an assigned portfolio of projects

This position is located in Rockville, Maryland. Remote work is possible.

Strong collaborative skills with ability to build relationships within multiple groups

Reports adverse events and near misses to appropriate management authority.

Skill in statistical programming, interpretation and data analysis using statistical software as well as spreadsheet and database software applications.

Ability to apply knowledge of scientific theory and computer capability to design and recommend changes to methods for clinical research.

Knowledge of best practice in Clinical Research.

Recruit and screen subjects for research studies.

Perform administrative duties such as providing training and guidance to other clinical research staff.