Clinical Data Associate
Hawthorne Effect
About Us
At Hawthorne Health, we believe that clinical research is the cornerstone of continuous improvement in healthcare. Clinical trials are about hope for patients of all ages and maladies, are the bedrock of medicine and innovation in healthcare, and their success is largely based on accessibility and patient experience.
We challenge convention, embrace creativity, and always keep the experiences for patients at the core of our endeavors. We believe that enabling better access to patients and their data is the key ingredient for trial success. Through the completeness of data, we see the full picture for individuals and communities. When protected and shared with trusted partners we support brining better medicines and devices for all. We believe that our team, our HERO community, and our technology solutions can make a significant contribution to the advancement of clinical research, making it more accessible, effective, less expensive and an all-around better experience for patients.
About the Role
The Clinical Data Associate role is an integral role designed to provide project support to the clinical operations team. As a Clinical Data Associate, you will be responsible for conducting the following under the oversight of the Clinical Operations Manager:
- Visit Management: Assist the Clinical Lead in ensuring timely and high-quality study visits:
- Provide ongoing Adverse Events, Medical History, and/or current medication list to Heroes so that Heroes are prepared for their visit.
- Assisting Clinical Leads in visit troubleshooting
- Post-Visit Data Management:
- Ensuring that the data from visits are uploaded to our platform in a timely fashion to ensure project success.
- Ensuring data is uploaded to any third-party vendor (i.e., core labs)
- Reviewing all uploaded data for completeness and data quality/integrity (ALCOA+)
- Escalate or mitigate data issues according to HE standards
- Assist the Clinical Lead in the reporting of Adverse Events in accordance with safety reporting timelines.
- Data Entry: You will be responsible for all data entry:
- Working closely with Clinical Leads and Project Managers to ensure all data is uploaded and entered in a timely manner.
- Working closely with Clinical Leads to ensure the data entered is accurate
- Working closing with Clinical Leads to ensure all Adverse Events are reported to the required parties
- Source Document Requisition and Distribution: You will be responsible for requesting medical records when the client requires it as well as providing all medical records and data to the correct parties.
- Submitting and following up on medical record requests
- Redacting Source Documents and ensure they are provided to the correct parties
- Query Resolution: You will be responsible for resolving all data queries.
- Assist Clinical Leads in ensuring our Heroes are visit-ready including the following:
- Equipment logistics, training, and troubleshooting
- Documentation training
- Support Clinical Success team when needed
- Misc. Responsibilities as needed or required by projects.
Position Requirements:
The ideal candidate is organized, efficient, takes initiative, is proactive in addressing issues, and is comfortable working in a deadline driven environment. This person is interested in expanding their repertoire of skills in the workplace and seeks out opportunities to do so; they will be passionate about our mission and about building an organization that will shape both patient and Hero experiences. S/he will bring to Hawthorne Effect the following skills:
- Associates degree from an accredited college or university or graduate of an allied health program (medical assistant, certified nurse aide, lab tech)
- Strong skills in the use of technology, tools, operating systems, and software and is comfortable using these daily
- Strong organizational skills with experience balancing priorities and resources
- At least 1-2 years RN or allied health experience, preferably with clinical trial experience (not required).
- If no RN or allied health experience, at least 1-2 years clinical trial experience (Clinical Research Coordinator) recommended.
- Strong skills in the use of technology, tools, operating systems, and software and is comfortable using these daily.
- Strong organization skills with experience with balancing priorities and resources.
- A creative and resourceful problem-solver with strong critical thinking skills.
- An expert at planning ahead, anticipating challenges and opportunities, and proactively taking steps to either avoid issues or operationalize new ideas.
- Able to work thoughtfully and decisively, anticipating the need to involve others, to foster an inclusive work environment that avoids unnecessary “fire drills” or “chaos”.
Preferred Qualifications:
Experience with electronic data capture (EDC) systems, including Oracle Clinical and/or Medidata Rave
Location:
This position is 100% remote. Occasional travel may be required for team meetings.
To find out more about Hawthorne Health, visit: https://hawthornehealth.com