At arenaflex, we're dedicated to revolutionizing the clinical trials industry by providing cutting-edge research solutions that transform lives. As a Quality Control Data Entry Specialist, you'll play a vital role in ensuring the accuracy and completeness of patient files, utilizing our state-of-the-art RealTime CTMS system. If you're a motivated, detail-oriented individual with a passion for healthcare and quality control, we invite you to join our dynamic team in Winter Park, FL.
**About arenaflex**
arenaflex is a leading clinical trial company that's pushing the boundaries of innovation in the healthcare industry. With a diverse team of passionate professionals, we're committed to delivering exceptional research solutions that improve the quality of life for communities worldwide. Our inclusive and collaborative work environment is built on the principles of diversity, equity, and inclusion, where everyone is valued, respected, and empowered to thrive.
**Job Summary**
As a Quality Control Data Entry Specialist, you'll be responsible for ensuring the accuracy and completeness of patient files by meticulously validating and entering data into our RealTime CTMS system. This role requires a keen understanding of healthcare quality, regulatory standards, and medical terminology. If you're a detail-oriented individual with excellent communication and interpersonal skills, we encourage you to apply.
**Responsibilities**
* Represent arenaflex in a professional and courteous manner when interacting with site staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals, and physician's offices.
* Conduct a thorough and precise review of study charts utilizing SOPs, policies, GCP, GDP, and sponsor protocols. Indicate data points that are missing or discrepant and identify and report any trends to the QC Manager, Team Leads, and upper management.
* Accurately enter data into an eCRF/CRF system according to the sponsor-provided eCRF/CRF guidelines in a timely manner.
* Identify and report missing data points or inconsistencies to the clinical research coordinator, QC Manager, Team Leads, and upper management as soon as possible.
* Attend SIV meetings.
* Report any discrepancies between the source and CRF/eCRF immediately to the CRC and the QC Manager, Team Leads, and upper management.
* Resolve open queries thoroughly, accurately, and in a timely manner.
* Assist in sponsor monitor visits to resolve queries in a timely manner.
* Possess the ability to work closely with other staff members and sponsor representatives in a professional manner.
* Assist with training onboarding procedures.
* Perform all duties in a timely and cost-effective manner.
* Additional duties as assigned by management.
**Qualifications**
* Bachelor's degree or commensurate experience
* At least 1 year of experience working in quality and/or data entry in healthcare. Clinical research experience is not required, but nice to have
* Familiar with working in a patient database, such as a CTMS
* Understanding of ICH, FDA, and GCP regulations
* Impeccable organizational skills and attention to detail
* Excellent communication and interpersonal skills to effectively interact with the site team
* An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
* High-level critical thinking skills
* Working knowledge of medical terminology
* Proficiency with computers and Microsoft Office Suite
**Benefits and Perks**
* Competitive hourly rate: $24-$28.85 per hour
* Comprehensive benefits package, including health, dental, and vision insurance plans, 401k with 4% match, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 10 company holidays
* Collaborative and inclusive work environment
* Opportunities for career growth and professional development
* Recognition and rewards for outstanding performance
* Flexible work arrangements and remote work options
**Why Join arenaflex?**
* Be part of a dynamic and innovative team that's transforming the clinical trials industry
* Contribute to research that improves the quality of life for communities worldwide
* Enjoy a comprehensive benefits package and competitive compensation
* Develop your skills and expertise in a supportive and inclusive work environment
* Make a meaningful impact in the lives of patients and families
**How to Apply**
If you're a motivated, detail-oriented individual with a passion for healthcare and quality control, we invite 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're committed to creating an inclusive and respectful work environment where everyone is valued, respected, and empowered to thrive.