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Gilchrist · 18 hours ago

Senior Research Program Coordinator II

Physicians Pavilion West

Full-time

Onsite

Senior Level

$57K/yr - $91K/yr

6+ years exp

Gilchrist is a healthcare organization seeking a Senior Research Program Coordinator II to assist principal investigators and research staff with multiple clinical research projects. The role involves managing regulatory review, training site study teams, monitoring data integrity, and overseeing patient enrollment while ensuring compliance with clinical research protocols.

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Responsibilities

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

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

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

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

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

Qualification

Clinical Research CoordinationDatabase ManagementRegulatory ComplianceAnalytical SkillsClinical Trials ExperienceOrganizational SkillsCommunication SkillsTeamworkProblem Solving

Required

Bachelor's Degree in related discipline required

At least six years' related experience

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

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