Job title

Study Feasibility Analyst I

Reports to

VP of Clinical Operations

Job Purpose

Work closely with Business Development, Data Science, Clinical Operations and Application Development to determine the feasibility of potential research projects. Design data queries, analyze results, prepare reports and communicate findings. Partner with network members to complete Site Feasibility Questionnaires. Assist in the refining of tools used to support data queries.

Duties and Responsibilities

• Collaborate with GRN colleagues to determine the feasibility of potential research

• Work with Data Scientists to develop data queries to satisfy requests from multi-disciplinary teams.

• Research a variety of medical conditions’ prevalence in addition to their diagnostic and treatment pathways.

• Read and interpret research inclusion and exclusion criteria.

• Track progress/actions in GRN study applications.

• Assist as needed with the analysis and interpretation of chart data in support of query result accuracy. 

• Communicate progress of feasibility requests proactively and independently.

• Handle other duties as assigned.

Training

• HIPAA

• Harassment

• CITI 

• GRN data elements and systems

• Assigned study/project protocols

• Workflow(s) required for assigned projects

• GRN HIPAA/Privacy & Security Training

Qualifications

Minimum Qualifications:

• BA/BS degree preferred; equivalent combined education and experience will be considered

• Basic understanding of Real-World Data (RWD) and/or clinical research fundamentals

• Basic understanding of following Policies, SOPs and WIs

Experience:

• Three (3) years’ experience working in data analytics, clinical research or a healthcare setting

Required Competencies/Knowledge, Skills and Abilities:

• Functional knowledge of data analytics, clinical research or the medical field.

• Ability to quickly learn new software applications.

• Strong written and verbal communication skills, and team-oriented approach.

• Strong presentation, documentation, and interpersonal skills, including to upper management and senior executives.

• Strong organizational skills, including ability to manage multiple deliverables across multiple projects.

• Excellent MS Office productivity skills, especially with MS Word and Excel

• Adaptable, flexible and solution oriented.

• Ability to complete tasks independently, accurately, and within compressed timelines.

Working conditions

• Day shift with standard working hours (8AM – 5 PM)

• Corporate office and/or home office environment with regular computer and phone usage.

Direct reports

None

Job title

Clinical Trial Analyst I

Reports to

VP of Clinical Operations

Job Purpose

Review medical charts to prescreen and refer clinical research study subjects and enter clinical trial data on behalf of GRN network sites using GRN technology.

Duties and Responsibilities

• Review medical records of patients identified by GRN technology as likely matches to a GRN clinical research study and determine eligibility.

• Maintain and manage “watch list” of those patients that are not currently eligible but may be in the future based on disease progression, resolved comorbidities, etc., to ensure timely enrollment when appropriate.

• Communicate specific patients’ eligibility and logistical information (e.g., date/time of next appointment, exam results, etc.) to onsite clinical research staff.

• Provide feedback to GRN IT regarding accuracy of technology-enabled patient lists

• Collaborate as necessary with GRN management and GRN network site staff to interpret information found in records (ambiguity, conflicting info, missing info, etc.).

• Locate protocol-required information in medical records of enrolled subjects and enter into study database in accordance with sponsor requirements, GRN policies/processes, and applicable regulations.

• Track progress/actions in GRN study applications.

• Communicate progress to Project Manager of each assigned clinical study.

• Handle other duties as assigned.

Training

• HIPAA

• Harassment

• CITI 

• GRN data elements and systems

• Assigned study/project protocols

• Workflow(s) required for assigned projects

• GRN HIPAA/Privacy & Security Training

Qualifications

Minimum Qualifications:

• BA/BS degree preferred; equivalent combined education and experience will be considered

• Understanding of clinical research fundamentals

• Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines, required

Experience:

One (1) year experience working in nursing, public health, clinical research, or health administration (prior oncology-focus and patient-facing roles strongly preferred).

• Required Competencies/Knowledge, Skills and Abilities:

• Functional knowledge of clinical research workflow and regulations.

• Ability to quickly learn new software applications.

• Strong written and verbal communication skills.

• Strong organizational skills, including ability to manage multiple deliverables across multiple projects.

• Excellent office productivity skills, especially with MS Word and Excel, as well as strong familiarity with clinical trials management software.

• Adaptability and flexibility.

• Ability to complete tasks independently, accurately, and within compressed timelines.

Working conditions

• Day shift with standard working hours (8AM – 5 PM)

• Corporate office and/or home office environment with regular computer and phone usage.

Direct reports

None