- Represent Flourish in a professional and courteous manner (verbal, written and in appearance) 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 and 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.
- Bachelor's degree or commensurate experience
- At least 1 year of experience working in quality and/or data entry in healthcare. Clinical research experienced 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
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Clinical Research Data Management Specialist - Plymouth Meeting, United States - Flourish Research
Description
Job Description
Job DescriptionFlourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
We are looking for a Clinical Data Management Specialist for our site in Plymouth Meeting, PA
The QC Data Entry Specialist ensures the accuracy and completeness of patient files by meticulously validating and entering data, utilizing the RealTime CTMS. This role requires a keen understanding of healthcare quality, regulatory standards, and medical terminology, although a clinical research background is not mandatory.
Shift: Monday-Friday, Normal Business Hours with overtime eligibility
Compensation: Hourly Rate based on experience + comprehensive benefits, PTO, and 401k match
*paid overtime for weekend work, evening work, or early morning work as needed
RESPONSIBILITIES
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
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