At arenaflex, we are committed to delivering exceptional services in the clinical research industry. As a leading provider of innovative solutions, we are seeking an experienced Clinical Data Entry Coordinator to join our Business Operations Team in Ridgefield, CT. This is a hybrid position that offers the flexibility of working from home and collaborating with our team in our office.
**About arenaflex**
arenaflex is a dynamic and growing organization that specializes in providing cutting-edge solutions to the clinical research industry. Our team of experts is dedicated to delivering high-quality services that meet the evolving needs of our clients. We are committed to fostering a culture of innovation, collaboration, and excellence, and we are seeking like-minded individuals to join our team.
**Job Summary**
We are seeking an experienced Clinical Data Entry Coordinator to support our Business Operations Team. The successful candidate will be responsible for entering accurate information into various applications, including the Investigator Database, Clinical Trial Management System (CTMS), and AGS360 or equivalent aggregate spend system. The ideal candidate will have highly proficient computer skills, with hands-on experience in multiple electronic platforms, and a strong understanding of ICH, GCPs, and applicable FDA guidelines.
**Key Responsibilities**
As a Clinical Data Entry Coordinator, you will be responsible for the following key duties and responsibilities:
* Entering accurate information into various applications, including the Investigator Database, CTMS, and AGS360 or equivalent aggregate spend system
* Creating, maintaining, and updating investigator and site data in the Investigator Database and CTMS based on new or updated Investigator Generic Screens, Investigator CVs, or related documents from internal and external sources
* Updating CTMS trial information related to investigators in the BIPI Investigator Database
* Creating, updating, and QC spend data and site data in AGS360 based on vendor-submitted trial spend data
* Monitoring Clinical Systems service mailboxes and performing tasks such as:
+ PI/site inquiries
+ External and internal referrals
+ Vetting requests
+ CTMS study site set up or update requests
+ File, retrieve, and distribute investigator and site-related documents based on the business process
+ Reviewing CTMS request and investigator information forms according to established quality standards for completeness and accuracy
+ Following the business process to complete the CTMS study site template request properly
+ Resolving quality issues with clinical personnel by requesting corrections and if needed, clarification in an expedited manner
* Ability to perform complex web-based research
* Creating and managing Excel spreadsheets/trackers
**Additional Responsibilities for DEC II**
As a DEC II, you will also be responsible for the following additional duties and responsibilities:
* Providing support for ad-hoc requests from business partners
* Creating and managing Excel spreadsheets/trackers, with proficiency in Excel (calculations and functions)
* Assisting with special projects/assignments, such as running reports and providing data analysis
* Assisting with Open Payments/Sunshine Act support, including:
+ Preparing data for Open Payments (Sunshine Act) for upload into AGS360 (e.g., CTSU drug data)
+ Assisting with vendors' spend data and inquiries, internal Clinical Trial Leader/Clinical Trial Manager inquiries on spend data
+ Reconciling data and identifying discrepancies to ensure data quality
**Requirements**
To be successful in this role, you will need to possess the following qualifications and skills:
* 4-year degree or relevant experience
* Highly proficient computer skills, with hands-on experience in multiple electronic platforms, such as:
+ Microsoft Office 365 Suite
+ MS Teams
+ SharePoint
+ Skype for Business
+ Adobe Acrobat Professional
* Expertise in currently assigned BI SOPs, BI WIs, and where applicable, Study Management & Conduct, Site Monitoring, Regulatory Document Group, or Investigational Product Clearance departmental practices and systems
* Understanding and maintenance of current knowledge of ICH, GCPs, and applicable FDA guidelines, US Federal Regulations pertaining to Clinical Trials and Guidance Documents and Information Sheets
**Preferred Qualifications**
* 2 years of experience with Microsoft Excel
* 2 years of experience with Microsoft Word
**Work Environment and Culture**
As a hybrid employee, you will have the flexibility to work from home and collaborate with our team in our office. We offer a dynamic and supportive work environment that fosters innovation, collaboration, and excellence. Our team is committed to delivering high-quality services that meet the evolving needs of our clients.
**Compensation and Benefits**
We offer a competitive salary range of $25.00 - $28.00 per hour, depending on experience. We also offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
**How to Apply**
If you are a motivated and detail-oriented individual with a passion for delivering exceptional services, we encourage you to apply for this exciting opportunity. Please submit your resume and cover letter to [insert contact information]. We look forward to hearing from you!
**Equal Employment Opportunity**
arenaflex is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to fostering a culture of inclusion and diversity, and we encourage applications from individuals with disabilities.