Bilingual Site Supervisor (English and Spanish)

We need to output HTML fragment with sections: h3 headings for sections present: About the role? The description includes "Position Summary". Could map to "About the role". Also "Key Responsibilities" -> Responsibilities. "Requirements Skills and Competencies:" and "Education and Experience:" combine into Requirements/Qualifications/Skills. Also "Physical Requirements" maybe part of Requirements. "Why JCCT" maybe Benefits? Not exactly benefits but could be "Benefits" or "About the company". The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Include a section ONLY when posting has real, specific content for it. So we need to decide which sections we have content for. We have: - Position Summary: can be About the role. - Key Responsibilities: Responsibilities. - Requirements Skills and Competencies: Skills/Competencies. - Education and Experience: Qualifications/Education. - Physical Requirements: could be part of Requirements but maybe separate? Not listed as a standard heading but could be included under Requirements or maybe omitted if not standard. The instruction says prefer a few substantive sections over many thin ones. So we could combine Skills and Qualifications into one Requirements section? But they gave separate headings possible: Requirements, Qualifications, Skills. We could have sections: Responsibilities, Requirements (including skills and competencies), Qualifications (education/experience). Benefits: we have "Why JCCT" describing company culture, maybe could be Benefits? Not exactly benefits like health insurance etc. Might be better to omit Benefits if not specific. Pay and Schedule: not present, so omit. Thus output:

About the role

... position summary ...

Responsibilities

• ... each responsibility ...

Requirements

• ... skills and competencies ...

Qualifications

• ... education and experience ...

We need to preserve all substantive information, not invent or summarize away detail. Must include all bullet points from responsibilities, skills, education, etc. Also include physical requirements? Might be omitted if not under standard headings; but we could include under Requirements as a bullet. However instruction: "Prefer a few substantive sections over many thin ones." Could add a subsection under Requirements for Physical Requirements but that would be thin. Better to incorporate physical requirements into Requirements list as a bullet. We must not repeat job title as heading. No Job ID etc. Remove boilerplate like EEO, etc. Also remove "Why JCCT" maybe not needed as it's not a standard heading; but could be considered "About the company" but not in list. Since not in allowed headings, we should omit it. However we might lose substantive info about company culture; but instruction says preserve ALL substantive information; but also says include a section ONLY when posting has real, specific content for it — never emit a heading followed by filler/placeholder text. The "Why JCCT" is substantive but not matching allowed headings. Could we treat it as "About the role"? No. Could we treat it as "Benefits"? Not really. Could we create a custom heading? The instruction says use h3 for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies we should use those headings; not that we cannot use others, but likely we should stick to those. The "Why JCCT" could be considered "About the company" but not in list; maybe we can omit as it's not a standard heading and might be considered filler? But it's substantive. However the instruction says preserve ALL substantive information; but also says do not invent or summarize away detail. If we omit that paragraph, we lose info. Could we incorporate it into "About the role" as extra paragraph? The About the role currently is position summary; we could add the Why JCCT paragraph there as additional description of the organization. That would preserve info without creating a new heading. That seems acceptable. Thus About the role will contain position summary plus Why JCCT paragraph. Now we need to extract the exact text. Position Summary: "The Site Supervisor is responsible for assuring the study team is accountable for performing assigned responsibilities in compliance with project plans, federal regulations, GCP and good medical practice. This position collaborates and participates with internal teams and external stakeholders to ensure all studies are adequately and appropriately resourced and delivered efficiently to timeline, budget and quality expectations. This position reports directly to the Site Director." Why JCCT paragraph: multiple sentences: "JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States. We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment. Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors. If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!" We should keep that as a paragraph after the position summary. Now Responsibilities: list bullet points from "Key Responsibilities". Let's extract each sentence separated by semicolons or periods. Key Responsibilities text: "Oversees leadership of the Clinical Operations team while ensuring site training/communications are occurringActively participates in the coordination of clinical trialsEnsures study compliance against protocol, SOPs, regulations and ICH/GCP guidelinesActs as a primary liaison with CRO/sponsors; establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelinesBuild and maintain strong relationships with investigators, referring physicians, and community partnersEnsures timely responses from clinical site staff and all regulatory agenciesDevelop strong, collaborative working relationships with CROs, sponsors, investigators, escalates to Site Director as neededWith input from the Site Director, allocates studies across teamsOversees that all study Start-Up activities are in place for any new study prior to consenting participants. Oversees ongoing study progress, data collection, and cleaning activities for all study trials under their purviewPrepares reports, drives site to hit KPIs and provides ongoing updates for leadership team/meetingsProvides oversight and mentors CRCs on source qualityInterviews and onboards new hiresConducts continuing performance management and annual reviewsWorks with QA to write, resolve and identify all CAPAsEnsure adherence to Good Clinical Practice (GCP), FDA regulations, and IRB requirementsCommunicates out of scope activities to ensure billing compliance and communicates all study invoiceables timelyEnsures staff work is “inspection ready” at all timesRepresent the site at industry meetings and conferences" We need to split into sensible bullet points. The text lacks punctuation; we need to infer separate responsibilities. Let's manually split based on verbs and conjunctions. I'll list: - Oversees leadership of the Clinical Operations team while ensuring site training/communications are occurring - Actively participates in the coordination of clinical trials - Ensures study compliance against protocol, SOPs, regulations and ICH/GCP guidelines - Acts as a primary liaison with CRO/sponsors; establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelines - Build and maintain strong relationships with investigators, referring physicians, and community partners - Ensures timely responses from clinical site staff and all regulatory agencies - Develop strong, collaborative working relationships with CROs, sponsors, investigators, escalates to Site Director as needed - With input from the Site Director, allocates studies across teams - Oversees that all study Start-Up activities are in place for any new study prior to consenting participants - Oversees ongoing study progress, data collection, and cleaning activities for all study trials under their purview - Prepares reports, drives site to hit KPIs and provides ongoing updates for leadership team/meetings - Provides oversight and mentors CRCs on source quality - Interviews and onboards new hires - Conducts continuing performance management and annual reviews - Works with QA to write, resolve and identify all CAPAs - Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and IRB requirements - Communicates out of scope activities to ensure billing compliance and communicates all study invoiceables timely - Ensures staff work is “inspection ready” at all times - Represent the site at industry meetings and conferences Now Requirements Skills and Competencies: list bullet points. Text: "Demonstrated relationship building skills through professional communication, interpersonal, analytical and problem-solving skillsDemonstrated ability to Coordinate complex protocols with overlapping timelinesMicrosoft Office Suite proficiency, technologically skilled in various systemsStrong study documentation skills in compliance with ALCOA+ preferredClose attention to detail and strong organizational skills to deliver high-quality work within project timelinesDemonstrates strong analytical, problem-solving skillMust be results oriented, multi-tasking and a quick learnerFamiliarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferredDemonstrated risk identification and mitigationAbility to effectively lead a teamAbility to prioritize and manage multiple projects simultaneouslyPrevious experience training and mentoring othersTime management skills" We need to split. Let's list: - Demonstrated relationship building skills through professional communication, interpersonal, analytical and problem-solving skills - Demonstrated ability to coordinate complex protocols with overlapping timelines - Microsoft Office Suite proficiency, technologically skilled in various systems - Strong study documentation skills in compliance with ALCOA+ preferred - Close attention to detail and strong organizational skills to deliver high-quality work within project timelines - Demonstrates strong analytical, problem-solving skill - Must be results oriented, multi-tasking and a quick learner - Familiarity with electronic case report form systems such as Medidata Rave, Inform, Trial Kit, etc. preferred - Demonstrated risk identification and mitigation - Ability to effectively lead a team - Ability to prioritize and manage multiple projects simultaneously - Previous experience training and mentoring others - Time management skills Now Education and Experience: bullet points. Text: "Minimum 4 years of experience in clinical researchStrong knowledge of relevant regulations ICH/GCP and FDA guidelinesEffective site management and organizational skills/ability to meet key study milestonesBS/BA in Life Science or related discipline or equivalent work experience Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)Previous nursing, medical assistant experience in a clinical setting a plusCCRC certification a plusDemonstrated relationship building, with strong verbal and written skills.Ability to successfully coordinate protocols with overlapping timelinesAbility to travel as needed: to support other sites, attend audits, attend meetings (Investigator Meetings, conferences, etc.)Ability to explain importance of GCP guidelines and their applicationAbility to train others on coordinating responsibilities and protocol adherenceAble to clearly explain and enforce clinical research participant safety requirements including ICF process, role of the IRB and adverse event reportingStrong interpersonal skills with attention to detail a mustProven ethical and professional codes of conductDemonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems." We need to split. List: - Minimum 4 years of experience in clinical research - Strong knowledge of relevant regulations ICH/GCP and FDA guidelines - Effective site management and organizational skills/ability to meet key study milestones - BS/BA in Life Science or related discipline or equivalent work experience - Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA) - Previous nursing, medical assistant