Senior Research Program Coordinator II

GBMC HealthCare • Towson, MD

1d • Onsite

About The Position

Under general supervision of the Research Nurse Manager, the Senior Research Program Coordinator II will assist principal investigators and research staff with multiple clinical research projects. This includes regulatory review, site study team training, data monitoring and integrity management, patient enrollment, and overall project timeline management for the GBMC Research Program. This requires a high level of knowledge, oversight, and organization, and will serve as a central resource for principal investigators and staff conducting clinical research. Responsibilities will also include orient and train research staff in the program and assist with general operations of the program.

Requirements

• Bachelor’s Degree in related discipline required. Master’s Degree preferred.
• At least six years’ related experience, experience in a clinical trials office preferred
• Advanced computer skills and knowledge of database management. (e.g., Microsoft Office, Medidata Database, Redcap Database)
• Organizational skills enabling many diverse tasks to be managed at the same time.
• Prioritization skills in order to manage a large caseload of both open and follow up trials.
• Analytical ability in order to develop and manage the data collection process, to process research data, and generate summary reports.
• Certification as a Clinical Research Associate from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals), required or eligible to obtain certification within a year of hire.

Nice To Haves

• Master’s Degree

Responsibilities

• Clinical Research Activities Assist principal investigators with multiple clinical research projects.
• Work on clinical studies requiring a high level of knowledge, coordination and data abstraction.
• Assist clinicians with patient screening, consenting and verification of patient eligibility for studies.
• Conduct intervention trials and international studies in compliance with International Council of Harmonization (ICH) regulations.
• Explain protocol procedures to patients and obtain informed consent.
• Contact patients at the appropriate time to assure completion of protocol requirements.
• Be responsible for organization and completeness of clinical research data, including data entry, maintenance of records and accuracy of the data.
• Design and compile materials and standard operating procedures which aid physicians and other staff in complying with protocol requirements.
• Establish study calendar of various clinical protocols and coordinate the logistics needed for successful completion of the studies.
• Collection, processing and shipping of biospecimen as requested by research protocols according to DOT/IATA regulations.
• Collect patient source documents and case report forms for analyzing patient data.
• Act as primary contact for study participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on campus.
• Perform assessment tools and questionnaires.
• Coordinate the collection and documentation of patient information for research purposes.
• Organize and create clinical research charts to be reviewed by regulatory agencies.
• Maintain a research database of patients enrolled in clinical trials.
• Participate in and or organize community events to increase public awareness.
• Regulatory Compliance Responsible for Institutional Review Board (IRB) submission, verification and maintenance of protocol specific information.
• Prepare and submit annual renewal requests, amendments and safety reports according to IRB requirements.
• Assist the Regulatory Specialist with new IRB submissions as needed.
• Ensure smooth study activation by working closely with the Regulatory Specialist, PI, and Research Nurse, and collecting all regulatory documentation.
• Work closely with Regulatory Specialist and clinical trial sponsor to ensure all documents are ready prior to study activation.
• Maintain regulatory binders per protocols.
• Establish regular meetings with PI, Research Nurse, and Study Coordinators to discuss protocol amendments, deviations, adverse events, and patient updates.
• Document adverse events and protocol deviations.
• Track each protocol amendment through the IRB approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.
• For Investigational New Drug (IND) studies, maintain accurate and up-to-date documents and submissions.
• Complete and maintain required certifications/training, e.g. CITI or DOT/IATA certification.
• Data Management Responsible for maintaining and promptly updating databases.
• Assist with preparation of data for reports and presentations.
• Design and implement procedural adjustments to increase accuracy and efficiency of data collection and entry process.
• Perform quality checks on data entry.
• Ensure accuracy and timeliness of data collection.
• Monthly review of monitoring reports along with the deviation log Interact regularly and help facilitate the completion of work with members of the research team regarding data management and the status and progress of ongoing studies.
• Maintain a continued high level of expertise in institutional databases including Epic, and IRBNet, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
• Research Program Oversight.
• Meet regularly with Principal Investigators to review and discuss research data and overall study progress.
• Work with the Research Directors and/or study sponsors on problem recognition/resolution, data accuracy and regulatory documentations as required by study sponsors.
• Prepare for and participate in monitoring visits and audits.
• Conduct periodic audits under the direction of the Research Nurse Manager and/or PI.
• Review subject eligibility and registration request.
• Assist PI with abstracts and manuscripts preparation.
• Provide training and preceptorship to Research Program Coordinators Assist Research Nurse Manager with program operations – providing suggestions for improved procedures, creating checklists and program-related Standard Operating Procedures.
• Complete minimum requirements for continuing education units.
• Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and GBMC policies.
• Ensure cancer center policies, standard operating procedures, and guidelines related to the conduct of clinical trials are followed.
• Financial Management Keep records of expenditures and work with budget analysts to ensure accurate and prompt reporting of study financials.
• Create clinical research budgets, oversee account activities, prepare invoices.

Benefits

• Competitive salary and generous paid time off
• Free parking
• Monthly MTA bus pass subsidy-85% paid by GBMC "if applicable"
• Company subsidized onsite fitness and wellness center "if applicable"
• Pre-paid tuition to pursue professional development, additional certifications, and degree programs
• Comprehensive health, dental, and vision coverage
• 401 (a) and 403 (b) retirement savings plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees