Careers

Lotus: Where Your Growth and Development = Our Success

Join the Lotus Clinical Research Team

Lotus Clinical Research seeks employees who are committed to excellence, quality, and the development of clinical research. We support our employees through professional and career development opportunities. We embrace a culture of openness, innovative thinking and deliberate decision makers. Join us today!

Available Positions

Clinical Trials Assistant (CTA)

Location: Remote

Job Description:

The Clinical Trials Assistant supports Clinical Operations to ensure studies are completed, on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. The CTA will archive and organize clinical trial master file documents, including clinical study site documents, generate filing indexes and maintain currents lists of correspondence.

Essential Duties and Responsibilities:

Assist in preparation of documents including regulatory document templates, study binders, study communications and presentations. Manage clinical, regulatory, and study-related essential documents such as study protocols, Informed Consent Forms, etc.
Assist with all aspects of initial study drug release including regulatory packet review and study-drug release.
Assist in the preparation and development of study-specific training materials.
Participate in the planning of investigator meetings.
Interact with sites as needed to respond to issues.
Handle incoming and outgoing shipments, as needed.
Monitor and track monitoring visit reports. Assist with tracking of clinical trial progress including status update reports, as required.
Participate in the review of clinical data at the case report form, data listing, and report table levels.
Collect enrollment updates and reports on a weekly basis.
Assist with tracking of clinical trial progress, as assigned.
Assist PM with set up and preparation of project meetings. May include scheduling the calls, gathering updates from the team, drafting, and finalizing of agenda, sending agenda to the team, and drafting and finalizing minutes.
File and QC trial master files.
Ensure documents are filed/uploaded into the eTMF in a timely and accurate manner.
Review and maintain up-to-date training records for the study team.
Document changes in study team members including updating the Study Contact Sheet.
Complete Study Plan Checklist for study Plans as assigned.
Identify and escalate issues appropriately.
May act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation.
Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.
Performs other miscellaneous related duties, as required.

Education and/or Experience:

BS/BA preferred. High school diploma/certificate or educational equivalent required.
Must possess a general knowledge of applicable clinical research requirements, including GCP and ICH guidelines.
Minimum of 2 years of clinical research experience required; one year CTA experience preferred but not required.
Demonstrated organizational and coordination skills with attention to detail.
Solid understanding of clinical drug development is preferred.

Skills and Abilities:

Strong Microsoft Office skills.
Strong written and verbal communication skills.
Effective time management and organizational skills.
Attention to detail and accuracy in work.
Strong customer service orientation.
Ability to work effectively and efficiently handling multiple tasks simultaneously.
Ability to facilitate a teamwork philosophy with a positive attitude.

CRO-Electronic Data Capture (EDC) Developer Contract Role

Job Title: Electronic Data Capture (EDC) Developer

Role: 6+ month contract

Candidate must be eligible to work in the US without requiring visa sponsorship

Location: Remote

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

Why join us?

We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

Essential Duties and Responsibilities:

Develop, program, validate and maintain EDC clinical trial databases in accordance with study protocols and/or source documentation. Lead post-production discussions and assist with closing functional gaps and required remediation.
Generate and maintain all required documentation related to programming activities; ensure quality of the programming and adherence to company standards.
Identify and recommend how to optimize CRO processes based on tool functionality.
Assist with management of external application vendor responsibilities, integrations, and implementations.
Proactively monitor scope of work to actual work, alerting management of potential change orders or resourcing needs.
Actively participate in database-related user groups, to include standard forms workgroups and process improvement workgroups.
Assists the Biostats and Data Management teams in the development and delivery of a variety of complex data processing, reports, and dashboards.
Provides technical guidance and leadership to less-experienced individuals regarding IT functions, EDC programming, etc.
Communicates with cross functional groups throughout the project lifecycle. Monitors project scope. Maintain a stron understanding of departmental and company procedures.
Maintains key vendor relationships such as EDC system vendors, etc.
Contribute to maintenance of EDC template database.
Identify processes that will increase productivity, quality and efficiency.
Performs other miscellaneous related duties, as required.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience:

BS/BA preferred. School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience.
Experience working in CRO industry preferred.
Working knowledge of CDMS/EDC systems and CDISC standards is a must.
Strong working knowledge of Clinical Research procedures and guidelines, required.
Extensive organizing and coordinating skills.
Solid understanding of clinical drug development is preferred.

Skills and Abilities:

Excellent organizational skills and attention to detail
Strong written and verbal communication skills.
Technology proficiency including Data Management Systems.
Study documentation production and maintenance, data processing, data review.
Knowledge of clinical research including regulatory requirement GCP/ICH Data Quality.
Strong interpersonal skills.
Strong computer skills, including Microsoft Office.

Language Skills:

Ability to read, interpret, and understand documents and reports containing pertinent information relating to the clinical research protocols.
Ability to respond effectively to all inquiries.
Ability to write routine reports and complete clinical documentation.
Ability to comprehend medical terminology.
Ability to effectively communicate with physicians, nurses, other team members, and representatives from outside organizations.

Mathematical Skills:

Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals.

Reasoning/Problem Solving Ability:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, or schedule form.

Physical Demands:

While performing the duties of this job, the employee is frequently required to use hands to finger, handle, or feel; stand; and talk or hear. Employee regularly reaches with hands and arms. The employee is periodically required to lift and/or carry up to 10 pounds. Occasionally, employee stoops, bends, kneels, and crouches; and pushes/pulls filled wheeled carts. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

Work Environment:

Works in a standard office environment where the noise level is usually quiet to moderate. Employee is subject to many interruptions; pressure due to deadline requirements; and handling multiple tasks simultaneously while performing assigned duties.

Safety Requirements:

Employee is required to pay particular attention to safety practices including following all safety, environmental, and infection control guidelines, procedures and protocols including wearing appropriate safety/protective equipment.