Clinical Research Coordinator 2

Georgetown University is an academic and medical research institution seeking a Clinical Research Coordinator 2 to support Cellular Therapy clinical trials through the Lombardi Clinical Trials Office. The role coordinates trials across their lifecycle, manages participant procedures and documentation, supports regulatory and sponsor interactions, and serves as a Cellular Therapy champion.

Responsibilities

Serving as Cellular Therapy champion

Liaise with Lombardi CTO, MedStar Health, and GUMC Departments, regarding the status of studies in the start-up process to support timely activation of new Cellular Therapy trials and provide regular updates for activated trials

Establish and maintain regular meeting cadence for Cellular Therapy clinical trials

Collaborate with Cellular Therapy Co-Leads to create, establish, and distribute meeting agendas and document/distribute minutes and actions items from each meeting

Schedule in-service training for appropriate staff assigned on clinical trials

Responsible for overall coordination of assigned clinical trials throughout the trial lifecycle

Interface with study participants and obtain and document informed consent according to protocol, institutional policies, and regulatory guidelines

Schedule and coordinate study-related procedures and assessments while maintaining protocol integrity and patient safety and in accordance with Good Clinical Practice (GCP) guidelines

Coordinate collection of research specimens per protocol requirements

Regularly update the Clinical Trials Management System (CTMS) with patient information and key dates to support responsible financial management of clinical trials

Collaborate with Data Coordinators(s) to ensure documentation for the clinical trial is complete and accurate in compliance with protocol and sponsor requirements; assist with query resolution in a timely manner

Schedule/facilitate sponsor meetings including PSV, SIV, MV

Document and report serious adverse events per protocol and institutional policy, with input from PI or senior member of clinical research team

Act as a liaison with hospital staff, physicians, IRB, review committees, clinical research finance team, and auditors

Conduct follow-up with study participants in accordance with established standards and protocols

Act as a liaison with sponsors during study start-up activities and participate in site initiation visits, monitoring visits, and audits

Identify potential barriers to patient and physician participation in clinical trials; develop and implement methods to alleviate those barriers

Actively participate in meetings and committees, as assigned

Other duties as assigned

Preferred

Three (3) to five (5) years of related experience in clinical research preferred

Three (3) to five (5) years of related experience in clinical research preferred.

Benefits

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Retirement savings

Tuition assistance

Work-life balance benefits

Employee discounts

Voluntary insurance options

Company

Student-centered Catholic Jesuit international research university

Washington, District of Columbia, USA

http://www.georgetown.edu/

Founded in 1789

5001-10000 employees

Qualifications

Bachelor's Degree in a scientific or health related field required

Excellent project coordination skills, verbal and written communication skills, organizational skills, attention to detail

Ability to work independently and function within a team

Knowledge of clinical research, research processes, and Good Clinical Practice (GCP)

Reliable and able to prioritize competing responsibilities

Three (3) to five (5) years of related experience in clinical research preferred

Required skills

Clinical Research, Clinical Practice (GCP), Clinical Trial Coordination, Human Subject Protection, HIPAA Compliance, Project Coordination

Preferred skills

Verbal and Written Communication

Experience

3-5 years