QC & Data Management Lead
Flourish Research · United States · 1 mo ago
RemoteRemoteQuality AssuranceFull-time
We need to output HTML fragment with sections: About the role? Actually the posting includes "About Us" and "About the Job". We need to use for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections when posting has real specific content. We need to extract content.
We have:
- About Us: description of company, mission, diversity, benefits, etc. This could be "About the role"? Actually "About the role" is not present; we have "About Us" and "About the Job". The instruction says use
.
Now Requirements: Minimum requirements:
Education: Bachelor's degree or commensurate experience.
Experience: Minimum of 2 years in the department plus 2 years in related role within the clinical research industry.
Must have industry certification, as applicable.
Also Knowledge and Skills: but we will move to Skills section. However the Requirements section currently includes "Knowledge and Skills:" paragraph. We could keep that as part of Requirements or move to Skills. To avoid thin sections, we could keep Knowledge and Skills under Requirements, and then have Skills section maybe not needed. But we already plan to have Skills section for the detailed list. Let's see: The Knowledge and Skills paragraph includes multiple sentences: "Consistently demonstrates core values & high proficiency in skills set. Must have the ability to understand medical terminology and research concepts. Must have the ability to identify appropriate subject care, relate in a professional and knowledgeable manner to physicians, pharmaceutical sponsors/CROs. Must have a basic knowledge of Good Clinical Practice (GCP), computer, internet, and Microsoft Office applications. Manage multiple tasks, ability to prioritize, meet deadlines, work independently, exercise initiative, demonstrate sound judgement, and consistently demonstrate effective oral and written communication. Develops and implements key initiatives in the department. Identifies and implements process improvements for increased efficiency. Builds and fosters relationships across teams. Consistently accomplishes 80% of individual goals each quarter. Serves as preceptor, mentor, and subject matter expert in the department. Demonstrates strong critical thinking and decision-making skills resulting in sound judgment. Flexible and able to multi-task and prioritize competing demands. Ability to think independently and influence when appropriate."
That's a lot; could be its own Skills section. So we could put Requirements: education, experience, certification. Then Skills: the knowledge and skills list.
Thus Requirements section will have three items (education, experience, certification). We'll put as
for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must only include sections when posting has real specific content. We need to extract content.
We have:
- About Us: description of company, mission, diversity, benefits, etc. This could be "About the role"? Actually "About the role" is not present; we have "About Us" and "About the Job". The instruction says use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should map content to those headings if appropriate. "About the role" could be the description of the job purpose etc. We have "About the Job:" with purpose and remote position etc. That could be placed under About the role
. Then responsibilities: list of essential job functions. Then requirements: minimum requirements etc. Qualifications maybe overlapping; but we can combine? The instruction says prefer few substantive sections over many thin ones. We need to decide which sections to include based on content.
We have content for:
- About the role: purpose, remote, shift, location, purpose statement.
- Responsibilities: essential job functions list.
- Requirements: minimum requirements (education, experience, certification, knowledge and skills). Could also include qualifications.
- Benefits: listed.
- Pay: not mentioned. So we should NOT include Pay section.
- Schedule: shift mentioned Monday-Friday 40 hours per week, occasional evening and weekend work schedules. That's schedule info. So we can include Schedule section.
- Skills: maybe part of knowledge and skills; but we could incorporate into Requirements or Qualifications. Since we have a Requirements section already, we could omit Skills to avoid thin sections. But we need to decide if we have enough content for Skills separate. The knowledge and skills list is extensive; could be its own Skills section. However instruction: prefer few substantive sections over many thin ones. So we could combine knowledge and skills into Requirements or Qualifications. But we have both Requirements and Qualifications as possible headings. We could put education/experience under Requirements, and knowledge/skills under Skills. That gives two substantive sections.
Qualifications maybe similar to Requirements; but we can decide to use Requirements for education/experience, Skills for knowledge/skills, and Benefits, Schedule, About the role, Responsibilities.
Thus sections: About the role, Responsibilities, Requirements, Skills, Benefits, Schedule.
We must not repeat job title as heading. No Job ID.
We must preserve all substantive information, not invent or summarize away detail. Must not include boilerplate like EEO etc. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. At end there is EEO statement; we should remove that.
Also remove duplicated lines? Not seeing duplicates.
We need to output only HTML fragment, no /, no markdown fences.
Thus produce something like:
About the role
About the role
. Then responsibilities: list of essential job functions. Then requirements: minimum requirements etc. Qualifications maybe overlapping; but we can combine? The instruction says prefer few substantive sections over many thin ones. We need to decide which sections to include based on content. We have content for: - About the role: purpose, remote, shift, location, purpose statement. - Responsibilities: essential job functions list. - Requirements: minimum requirements (education, experience, certification, knowledge and skills). Could also include qualifications. - Benefits: listed. - Pay: not mentioned. So we should NOT include Pay section. - Schedule: shift mentioned Monday-Friday 40 hours per week, occasional evening and weekend work schedules. That's schedule info. So we can include Schedule section. - Skills: maybe part of knowledge and skills; but we could incorporate into Requirements or Qualifications. Since we have a Requirements section already, we could omit Skills to avoid thin sections. But we need to decide if we have enough content for Skills separate. The knowledge and skills list is extensive; could be its own Skills section. However instruction: prefer few substantive sections over many thin ones. So we could combine knowledge and skills into Requirements or Qualifications. But we have both Requirements and Qualifications as possible headings. We could put education/experience under Requirements, and knowledge/skills under Skills. That gives two substantive sections. Qualifications maybe similar to Requirements; but we can decide to use Requirements for education/experience, Skills for knowledge/skills, and Benefits, Schedule, About the role, Responsibilities. Thus sections: About the role, Responsibilities, Requirements, Skills, Benefits, Schedule. We must not repeat job title as heading. No Job ID. We must preserve all substantive information, not invent or summarize away detail. Must not include boilerplate like EEO etc. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. At end there is EEO statement; we should remove that. Also remove duplicated lines? Not seeing duplicates. We need to output only HTML fragment, no /, no markdown fences. Thus produce something like:About the role
...
Responsibilities
- ... ...
Requirements
- ... ...
Skills
- ... ...
Benefits
- ... ...
Schedule
...
We need to ensure we preserve all substantive information from the posting. Let's extract content. About the role: From "About the Job:": We are actively hiring a QC & Data Management Lead. This is a remote position. Shift: Monday-Friday (40 hours per week) Location: Remote- United States PURPOSE: Assure quality research data is collected by adhering to Flourish Standard Operating Procedures (SOPs), GCP, FDA, and protocol guidelines for all subject data that is submitted into the QC data entry department. Work closely with clinical research coordinators (CRCs) and ensure that the QC data entry department is utilizing the Punctual Accurate Complete True (P.A.C.T.) System. Assist clinical research associates (CRAs) during internal monitoring visits. We should keep all that. Not repeat job title as heading, but we can include it in paragraph. Thus About the role paragraph: "We are actively hiring a QC & Data Management Lead. This is a remote position. Shift: Monday-Friday (40 hours per week). Location: Remote- United States. PURPOSE: Assure quality research data is collected by adhering to Flourish Standard Operating Procedures (SOPs), GCP, FDA, and protocol guidelines for all subject data that is submitted into the QC data entry department. Work closely with clinical research coordinators (CRCs) and ensure that the QC data entry department is utilizing the Punctual Accurate Complete True (P.A.C.T.) System. Assist clinical research associates (CRAs) during internal monitoring visits." We could also include the "About Us" description? That is more about company; but we have no heading for About Us. Could we incorporate into About the role? Probably not; but we could add a brief paragraph about company under About the role? The instruction says use headings for sections; we could add an "About the company" but not in list. Better to omit About Us because not requested heading; but we must preserve ALL substantive information. The About Us contains substantive info about company mission, diversity, benefits etc. However benefits are already covered elsewhere. The mission and diversity statements could be placed under About the role? Might be okay to add a paragraph after purpose about company values. But the instruction says we should not invent or summarize away detail. We need to preserve all substantive information. So we need to include the About Us content somewhere. Where could we put it? There's no heading for About Us, but we could incorporate it into About the role section as a paragraph describing the company. That would preserve it. Thus About the role section will have two paragraphs: first about the job details, second about company description (From "About Us:"). Let's extract About Us text: "Flourish Research is where clinical trials thrive. Flourish Research is one of the industry's most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. 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 is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. 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! Flourish 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 need to preserve all that. Note that the last sentence about benefits repeats benefits; we will also have Benefits section later; but we should not duplicate content. However instruction says preserve ALL substantive information; we could include it in About the role but then also have Benefits section; that would duplicate the benefits sentence. Might be considered duplication. The instruction also says remove duplicated lines. So we should avoid duplicating the benefits sentence. We could omit the benefits sentence from About Us paragraph, but that would be removing substantive information (the benefits mention). However we will have a Benefits section that lists specifics; the generic statement about offering an excellent comprehensive benefits package is substantive but could be considered redundant with Benefits section. To avoid duplication, we could keep the generic sentence in About Us paragraph and not repeat the same generic statement in Benefits section; but Benefits section will list specifics, not the generic statement. So it's okay to keep the generic sentence. Thus we will include About Us paragraph minus the duplicated benefits sentence? Actually we can keep it; it's not duplicated exactly because Benefits section will list specifics; the generic sentence is not identical to any list item. So fine. Now Responsibilities: essential job functions list. Let's extract each bullet: - Conduct a thorough and precise review of all study charts utilizing Flourish SOPs and sponsor-provided protocols. - Accurately enter data into an eCRF/CRF system according to the sponsor provided eCRF/CRF guidelines in a timely manner. - Identify and report any missing data points or inconsistencies to the CRC in a timely manner to ensure all data is clean and accurate. - Source document creation/approval. - Report any discrepancies between the source and CRF/eCRF immediately to the primary CRC and/or Team Lead. - Notify Operations Leadership, Team Lead, and CRC of any major discrepancies and deviations in a timely manner. - Resolve open queries thoroughly, accurately and in a timely manner. - Assist in sponsor monitor visits to resolve queries in a timely manner. - Perform all assigned duties in a timely- and cost-effective manner. - Actively learn and seek opportunities to expand expertise as a Lead, QC & Data Management. - Oversee quality/quantity of QC & Data Management Specialists to ensure that all assigned tasks are completed accurately and in a timely manner. - Perform employee 1:1s. - Conduct regular team meetings. - Train new employees regarding QC/DE processes. - Attend pre-study visits (PSVs) and site initiation visits (SIVs). - Attend manager meetings. - Efficiently and effectively oversee the QC Data Entry department. - Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors. - Additional duties as assigned by management. We need to preserve all. We'll put each as- ... etc. Now Skills section: we need to break the knowledge and skills into list items. Could be each sentence as a list item. We'll