Senior Research Program Coordinator II

Education

Bachelor's Degree in related discipline required. Master's Degree preferred.

Experience

At least six years' related experience, experience in a clinical trials office preferred

Knowledge, Skills and Abilities

• 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.

Licensures, Certifications

• 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.

Principal Duties and 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.

Working Conditions

• Works in normal office environment with little exposure to excessive noise, dust, temperature extremes and the like.

All roles must demonstrate GBMC Values:

Respect

I will treat everyone with courtesy. I will foster a healing environment.

• Treats others with fairness, kindness, and respect for personal dignity and privacy
• Listens and responds appropriately to others' needs, feelings, and capabilities

Excellence

I will strive for superior performance in every aspect of my work. I will recognize and celebrate the accomplishments of others.

• Meets and/or exceeds customer expectations
• Actively pursues learning and self-development
• Pays attention to detail; follows through

Accountability

I will be professional in the way I act, look and speak. I will take ownership to solve problems.

• Sets a positive, professional example for others
• Takes ownership of problems and does what is needed to solve them
• Appropriately plans and utilizes required resources for various job duties
• Reports to work regularly and on time

Teamwork

I will be engaged and collaborative. I will keep people informed.

• Works cooperatively and collaboratively with others for the success of the team
• Addresses and resolves conflict in a positive way
• Seeks out the ideas of others to reach the best solutions
• Acknowledges and celebrates the contribution of others

Ethical Behavior

I will always act with honesty and integrity. I will protect the patient.

• Demonstrates honesty, integrity and good judgment
• Respects the cultural, psychosocial, and spiritual needs of patients/families/coworkers

Results

I will set goals and measure outcomes that support organizational goals. I will give and accept help to achieve goals.

• Embraces change and improvement in the work environment
• Continuously seeks to improve the quality of products/services
• Displays flexibility in dealing with new situations or obstacles
• Achieves results on time by focusing on priorities and manages time efficiently

Pay Range

Final salary offer will be based on the candidate's qualifications, education, experience and alignment with our organizational needs.

Equal Employment Opportunity

GBMC HealthCare and its affiliates are Equal Opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law.