Lead Clinical Research Coordinator

3 weeks ago

Annapolis, Maryland, United States Javara Full time

*** This position requires a minimum of three years of direct patient interaction in clinical research. The compensation package begins at $80,000.00 and is commensurate with experience.

Overview:

As a Lead Clinical Research Coordinator at Javara, you will play a pivotal role in the orchestration and management of clinical studies, reporting directly to the Site Operations Manager and the Principal Investigator or their delegate. Your contributions will be essential in enhancing patient enrollment initiatives across a diverse range of clinical trials. You will be instrumental in fostering continuous improvement by offering innovative solutions and strategies that ensure study success, exceptional participant experiences, and seamless integration of clinical research with our healthcare collaborators. With a primary focus on participant safety, you will implement and oversee research study protocols to ensure the effective management of clinical trials.

Key Responsibilities:

  • Enhance the patient experience while maintaining the highest safety standards.
  • Deliver outstanding service to patients, participants, healthcare partners, investigators, sponsors, and vendors.
  • Act as the primary Clinical Research Coordinator for multiple clinical trials, managing complex enrollment goals tailored to site-specific requirements by developing and executing enrollment strategies that meet and exceed expectations. May also serve as a lead coordinator across Javara for a specific study, providing support and mentorship to other assigned coordinators.
  • Implement the enrollment strategy for assigned studies to achieve target goals by identifying and engaging potential participants, screening candidates for suitable studies, and offering guidance to clinical operations team members as necessary.
  • Support enrollment objectives by contributing to patient retention initiatives and cultivating relationships within local communities.
  • Devise innovative strategies for patient recruitment and retention, including active participation in community outreach.
  • Ensure the scientific integrity of data by accurately documenting source data, including patient visit information within source documents, Clinical Trial Management Systems (CTMS), electronic reporting platforms, and timely resolution of queries.
  • Maintain up-to-date study documentation that is audit-ready, including the reporting of adverse events and deviations related to investigational products.
  • Comply with all Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), study protocols, OSHA regulations, proper use of Personal Protective Equipment (PPE), and other regulatory requirements.
  • Identify and propose solutions for opportunities within study protocols to enhance the overall experience for patients, investigators, healthcare partners, and other stakeholders.
  • Conduct and document the informed consent process.
  • Educate the research team and healthcare system staff on study-related procedures, including investigational product dosing and monitoring requirements.
  • Coordinate and schedule patient visits, ensuring compliance with study protocols.
  • Effectively communicate and escalate issues to ensure responsiveness and resolution with healthcare partners and external stakeholders.
  • Perform clinical and laboratory tasks, including obtaining vital signs, conducting EKGs, and collecting, processing, and shipping biological samples.
  • Demonstrate a commitment to continuous improvement that supports site success.
  • Exemplify our Core Values by promoting teamwork, collaboration, and building relationships with healthcare system representatives.
  • Undertake additional responsibilities as assigned.

Qualifications:

  • Associate's or Bachelor's Degree in a relevant field or equivalent industry experience.
  • A minimum of 3 years of experience in clinical research, including hands-on application of clinical functions such as obtaining vital signs, conducting EKGs, and performing phlebotomy.

Work Environment:

The characteristics of the work environment described here are representative of those an employee may encounter while performing the essential functions of this role.

  • This position operates in a professional setting.
  • The noise level in this work environment is typically light to moderate.

Physical Demands:

The physical demands outlined here are representative of those that must be met to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this role.

  • The employee will regularly use hands to reach, handle, or feel objects, tools, or controls, and will need to talk and hear.
  • The employee may frequently stand, walk, and sit.
  • The employee may occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required include close vision, distance vision, and the ability to adjust focus.

Pre-Employment Screening: A drug screening and background check are required.

This job description encompasses the essential functions of this position and is not intended to be an exhaustive list of activities, duties, or responsibilities required of the employee in this role. Duties, responsibilities, and activities may change at any time with or without notice.

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