Research Coordinator GCM Specialty Team
About The Position
The Research Coordinator GCM Specialty Team is responsible for the clinical and administrative coordination of sponsored clinical trials, research protocols/projects, and biospecimen collection studies. This role provides guidance to physicians, clinical staff, and research team members. The coordinator will manage assigned research studies from start-up through close-out, including IRB submissions, subject recruitment and enrollment, ensuring adherence to protocols, maintaining documentation, collecting data, managing study drugs/devices, reporting adverse events, and facilitating quality assurance. They will act as a liaison between sponsors and investigators, serve as the primary protocol contact, and develop educational plans for research staff and clinical teams. Responsibilities also include reviewing protocol amendments, research orders, study-specific workflows, and ensuring laboratory requirements for specimen handling are met. The position involves serving as a Primary Research Coordinator across multiple sites, guiding research teams, and coaching/mentoring personnel. Competency in research computer applications and participation in educational programs are also required. Licensed nurses will utilize advanced assessment skills and provide professional nursing care to research patients.
Requirements
- Bachelor's Degree in Biology, or Bachelor's Degree in Health Science, or Bachelor's Degree (or equivalent knowledge) in Nursing or related field.
- Typically requires 2 years of experience in Research.
- Knowledge of Good Clinical Practices, International Conference of Harmonization, FDA Guidance documents, Department of Health and Human Services regulations, standard operating procedures.
- Ability to successfully conduct and manage a research study.
- Ability to mentor team members and to prepare training plans.
- Excellent verbal and written communication skills, organizational and time management skills with ability to work under pressure and meet deadlines.
- Ability to problem solve and work independently with a high degree of accuracy and attention to detail.
- Must be able to establish a good rapport with patients, investigators and sponsors.
- Competency in using Electronic Medical Record (EMR), Microsoft Office Suite, and other computerized programs
- Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders and twist throughout shift.
- Must have functional sight and hearing.
- Ability to function in a latex environment.
- May be exposed to mechanical, electrical, chemical, and radiation hazards as well as blood and body fluids on a continuous basis; therefore, protective clothing (i.e., gown, mask, goggles, gloves, etc.) must be worn as necessary.
- Exposed to a normal office environment.
- Operates all equipment necessary to perform the job.
- Position may require travel among sites and therefore there is exposure to road and weather conditions.
Nice To Haves
- None Required.
Responsibilities
- Performs clinical and administrative coordination of sponsored clinical trials, research protocols/projects, and biospecimen collection studies, as applicable.
- Provides guidance to physicians, clinical staff and research team members.
- Coordinates assigned research studies in collaboration with other team members and key stakeholders, including but not limited to; study start-up, review of study CTA/budget/CTMS, IRB submissions, recruitment, screening, and enrollment of research subjects, development of mechanisms to maximize subject adherence to the research protocol, maintain source documentation, data collection (i.e. development, completion and submission of case report forms (EDC), study drug/device accountability, monitoring of subjects, AE/SAE reporting, study close out, and facilitates quality assurance inspections and audits.
- Acts as a liaison between sponsor and investigators and as the primary protocol/project contact for team members and clinical staff.
- Plans, develops and implements educational plans to disseminate protocol/project information with research staff, investigators and clinical staff.
- Reviews protocol amendments and updates, research related orders (in collaboration with Investigational Drug Services), and study-specific workflows.
- Ensures that laboratory requirements are being met for specimen procurement, proper collection, processing and shipment of specimens.
- Serves as Primary Research Coordinator on studies across multiple sites guiding research team members involved in the study and coordinates and tracks research activities across sites.
- Coaches and mentors research team members and other personnel.
- Assist with implementation of educational training plans including orientation.
- Maintains competency in research computer applications
- Attends and participates in educational programs, meetings, and assigned committees.
- Licensed nurses will utilize advanced assessment skills to identify patient care problems, provide professional nursing care to research patients and support Research Coordinators in performing nursing activities as needed.
Benefits
- Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
- Premium pay such as shift, on call, and more based on a teammate's job
- Incentive pay for select positions
- Opportunity for annual increases based on performance
- Paid Time Off programs
- Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
- Flexible Spending Accounts for eligible health care and dependent care expenses
- Family benefits such as adoption assistance and paid parental leave
- Defined contribution retirement plans with employer match and other financial wellness programs
- Educational Assistance Program
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
