Careers
Here at Ploutos Baker; we offer career opportunities and not jobs. We are seeking talented professionals to fill numerous roles with some of our growth partners and within our ever-growing team of consultants.
If you are interested in highly exciting, rewarding, and fulfilling career opportunities; then we want to meet you.
CLINICAL DATA MANAGER
The Clinical Data Manager is responsible for working with internal project team members to provide data management services for our customers to ensure timely and accurate deliverables. Responsibilities include providing data management guidance to internal project team members and customers; communicating with internal project team members and customers on all aspects of data management activities performed for a study; authoring data management documents; performing user acceptance testing on data management deliverables; and facilitating and verifying data clarifications and data changes.
- Collaborate across functional groups to address technical issues impacting quality, drive forward technical initiatives within Data Management
- Provides data management guidance to internal project team members and customers
- Communicates with internal project team members and customers on all aspects of data management activities performed for a study
- Authors data management plans (DMP)
- Authors data transfer specifications (DTS)
- Performs user acceptance testing on reports specified in the DMP
- Performs user acceptance testing on automated data checks programmed to support the data cleaning activities specified in the DMP
- Reviews, makes decisions, and acts upon output from automated data checks
- Facilitates risk assessments for mid-study changes
- Verifies data extracts against the DTS
- Provides proactive data monitoring per contractual obligations
- Facilitates and verifies data clarifications and data corrections
- Facilitates and verifies external data reconciliation
- Contribute to the development and update of process improvements that reduce processing times, increase quality, mitigate operational risks, improve team performance, and meet departmental objectives and corporate objectives
- Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget
- Performs all work in accordance with documented Standard Operating Procedures (SOPs), Working Instructions and Best Practices
- Assists in developing and improving Standard Operating Procedures (SOPs), Working Instructions and Best Practices
- Dedication and commitment to promote diversity, multiculturalism and inclusion in all work activities
- Ability to collaborate in diverse teams to foster productive outcomes.
Essential
- BA/BS degree in a relevant field (Medicine, Statistics, Computer Science) or equivalent work experience
- Strong verbal and written communication skills
- Ability to complete high quality technical documentation
- Demonstrate extreme attention to detail and organization in all aspects of work
- Ability to quickly learn and apply new skills, procedures and approaches.
- Demonstrated ability to meet very short deadlines & multi-task in an extremely fast-paced work environment with little direct supervision
- Proven ability to work both independently and in a team-oriented environment, providing back-up support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas
- Proactive and positive approach to tasks and projects overall, as well as to the types of scheduling & process changes that are inherent in a fast-paced business
Desirable
- 5+ years of professional experience in the clinical trials data management field
- Experience in providing data management services in the clinical trials industry
- Proficient in Access, Excel, and other office software technologies and applications.
- Proven ability to handle multiple competing priorities in a fast-paced work environment with minimal direct supervision.
- Familiarity with 21 CFR Part 11 or experience in a regulated environmendesirable
Ploutos Baker, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
COVID-19 Recruitment Information: Ploutos Baker, LLC is monitoring COVID-19 activity. The health and wellbeing of our staff is of the utmost importance to us, and we continue to hire for all open roles with interviewing and on-boarding done virtually. Our new hires and current staff working from our Texas and Maryland offices will continue to work from home until our management team decides otherwise or it is safe to return to our offices.
CLINICAL RESEARCH ASSOCIATE
Ploutos Baker is seeking a Clinical Research Associate to be a critical member of the clinical operations team. The Clinical Research Associate will be responsible for management of assigned investigator sites and all monitoring activities for assigned studies. Clinical affairs duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.
- Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan.
- Conduct on-site and remote study monitoring and site management.
- Assist project manager with clinical study planning and management, as required.
- Assist Clinical Trial Manager with drafting protocol-specific manuals, plans, and documents as needed.
- Develop and maintain positive relationships both internal and external to the project, including clients, team members, and site personnel (PIs, Study coordinators, etc.).
- Assist in the identification and recruitment of potential investigators and study sites.
- Verify site qualifications and capabilities to conduct clinical studies.
- Assist Clinical Trial Manager and In-House CRA with ensuring that Trial Master File is accurate and complete throughout the lifecycle of the project.
- Prepare and conduct site training for assigned clinical trials.
- Assist with site audits and site quality management activities as needed.
- Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current developments in the assigned therapeutic areas.
- Bachelor’s degree (B.A./B.S.) in life sciences, healthcare or a related scientific discipline or Registered Nurse/Allied Health Professional with clinical research experience.
- 2+ years of professional experience required
- Minimum of 1 year of direct, on-site clinical trial monitoring experience required
- Medical device experience is a plus
- Knowledge of ICH guidelines for GCP
- Knowledge of clinical monitoring procedures and best practices
- Experience using Electronic Data Capture (EDC) and clinical trial management systems
- Strong written and verbal communication and presentation skills
- Strong research, analytical, critical-thinking, and problem-solving skills
- Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications
- Ability to read, write, speak, and understand English
- Travel (75%) required for this position
- Salary + bonus
- Medical, dental and vision insurance
- Company-paid life insurance
- Company-paid STD and LTD
- 401(k) + company match
- Generous PTO policy
- Fully paid maternity leave benefits
- Pre-tax public transit and parking benefit
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.
Ploutos Baker, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
COVID-19 Recruitment Information: Ploutos Baker, LLC is monitoring COVID-19 activity. The health and wellbeing of our staff is of the utmost importance to us, and we continue to hire for all open roles with interviewing and on-boarding done virtually. Our new hires and current staff working from our Texas and Maryland offices will continue to work from home until our management team decides otherwise or it is safe to return to our offices.
EMR AMBULATORY ANALYST
Ploutos Baker seeking an Ambulatory Analyst to work on a remote team for a client project. We have several projects scheduled through 2032 that provide the opportunity to convert to full time with our client. In order to be considered for potential to convert, working in the local area is required. After conversion, there will be a need to come to the site if business needs arise.
- Ambulatory Analyst will be responsible to implement, build, maintain and optimize the EMR system.
- They have knowledge of the EHR software, operations and workflow, and work closely with the project team’s clinical leaders to translate business needs into EHR functionality.
- An analyst is expected to have EHR knowledge and build expertise in orders (lab, rad, procedures etc.), charge capture and general ambulatory.
- Analyst is expected to be able to work with clinics to translate workflows to EHR functionality, identify gaps, and provide mutually agreeable solutions to close workflow gaps.
- Involves design, building, testing, and implementation of clinical application systems.
- Provides support to clinical users through knowledge of clinical processes, documentation needs, workflows, and clinical practice standards, when adapting software to meet their needs.
- Works with clinicians to create or adapt written protocols.
- Prepares detailed specs encompassing clinical processes, information flow, risk and impact analysis.
- May provide customer service, troubleshooting, and maintenance.
- Seven (7) years of related experience, education/training in relevant EHR; OR a Bachelor’s degree in related area plus three (3) years of related experience/training in EHR.
- Required to be certified in an assigned EMR vendor’s product/module within the first six (6) months of employment.
- Must satisfy all vendor testing requirements to be certified without needing to attend vendor’s training a second time for the same class.
- Experience and proven success in information systems implementation, development and support within a large-scale healthcare organization.
- Demonstrated ability to provide expert consultative guidance and direction on change initiatives affecting clinical care processes.
- Proven ability in workflow and data analysis and design techniques, including needs assessment, specification development, quantitative methods, planning and gap analysis.
- EHR Software Certification.
- Experience as a major participant in a clinical system implementation.
Ploutos Baker, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.
COVID-19 Recruitment Information: Ploutos Baker, LLC is monitoring COVID-19 activity. The health and wellbeing of our staff is of the utmost importance to us, and we continue to hire for all open roles with interviewing and on-boarding done virtually. Our new hires and current staff working from our Texas and Maryland offices will continue to work from home until our management team decides otherwise or it is safe to return to our offices.