When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: - Manage external vendors and contract research organizations - Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual - Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents - Assist with protocol development and study report completion - Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols - Provide guidance, direction, and management to CRAs - Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities - Coordinate study supplies - Negotiate contracts with vendors of clinical trial services - Review Informed Consent Forms, CRFs, and study related materials - Plan and participate in investigator meetings - Assist and support data query process - Ensures trial master file is current and maintained - Collaborate in the management of external vendors and contract research organizations to ensure efficient execution of clinical trials. Skills: - Oversee all aspects of clinical trials from initiation to closeout, ensuring timely completion within budget through effective project management. - Identify and resolve issues that arise in a timely manner during trial execution to minimize delays and maintain study integrity, employing strong problem-solving abilities. - Effectively manage multiple tasks, deadlines, and priorities in a complex clinical trial environment - Clearly convey information and expectations to cross-functional teams, investigators, and stakeholders Knowledge and Experience: - Good Clinical Practices (GCPs) and regulatory compliance (FDA and ICH guidelines) - Experience in clinical trial documentation and processes (e.g., protocols, CRFs, monitoring plans) - Experience of data management and query resolution in clinical trials - Overall knowledge of site management and monitoring procedures Education: - Degree in the life sciences field preferred

• Perform the day-to-day management of early phase clinical trials or support the study lead(s) on one or more complex global clinical trials. • Develop and execute clinical trial plans, including study timelines, budgets, and resource allocation. • Manage trial budgets, contracts, and vendor relationships. • Collaborate with investigators, clinical sites, and key opinion leaders to ensure successful trial execution. • Ensure the timely initiation, monitoring, and close-out of clinical trial sites, including the selection of qualified investigative sites. • Oversee patient recruitment and retention strategies, ensuring trial objectives are met. • Oversee vendors and investigative sites in the collection and management of clinical data to fulfill study objectives. • Proactively identify and mitigate risks and challenges throughout the course of the trial. • Ensure strict compliance with Good Clinical Practice (GCP) guidelines and relevant regulations. • Prepare for and manage audits and inspections by regulatory authorities.

Dane Street wants you to join our dynamic team of expert reviewers! In this role, you will have the opportunity to utilize your medical expertise to conduct thorough reviews of clinical cases. This telework opportunity allows you to customize your schedule as a 1099 independent contractor. Your main task will be to evaluate medical records, provide clinical summaries, engage in peer communications, and answer specific questions posed by our clients. We are on the lookout for talented professionals in the following area: - Clinical Genetics Be a part of a team that values your skills and dedication to improving patient care. Your expertise is vital to helping us deliver high-quality healthcare assessments.

Job Title: Remote Clinical Care Coordinator (RN) Position Type: Full-time Work Schedule: 8:30 AM – 5:30 PM Pacific Daylight Time Salary: $6–$7 per hour (depending on experience) Preferred Candidate Location: Philippines About Our Client Our Client is looking for a highly skilled Remote Clinical Care Coordinator (RN) to support referral intake, clinical review, discharge coordination, and proactive patient follow-up within a home health environment. This role functions as a clinical liaison and operational lead for referral intake, eligibility determination, risk stratification, and care coordination, helping ensure patients receive safe and appropriate care while reducing avoidable hospital readmissions. The ideal candidate is a confident clinical professional who can assess patient needs, identify potential complications, and coordinate effectively with physicians, hospitals, clinicians, and patients. Key Responsibilities Referral Intake & Clinical Review - Receive, log, and triage referrals from hospitals, skilled nursing facilities (SNFs), physicians, and community partners. - Review clinical documentation such as H&P, discharge summaries, therapy notes, progress notes, and physician orders to ensure accuracy and completeness. - Communicate with referral sources to obtain missing documentation or clarify clinical needs - Determine whether patients are appropriate for home health services based on clinical risk and operational capacity. Eligibility Screening for Home Health Services - Screen referrals to ensure patients meet home health eligibility requirements, including homebound status, skilled nursing or therapy needs, and physician oversight with valid orders. - Verify insurance coverage such as Medicare, Medicare Advantage, Medicaid, and commercial plans. - Confirm service area coverage and staffing availability before patient acceptance. Clinical Risk Stratification & Acuity Assessment - Assess the risk of hospital readmission and identify high-risk patients based on factors such as recent hospitalizations or SNF stays, multiple or unstable comorbidities, polypharmacy or complex medication regimens, and limited caregiver support or other social risk factors. - Escalate high-risk cases to clinical leadership when necessary. Identification of Clinical Complications - Screen referrals for high-acuity needs such as complex wounds or infection risks, IV therapy including PICC or central line care, enteral feeding tubes (NG, G-tube, or J-tube), catheter or ostomy management, and respiratory support such as oxygen therapy, tracheostomy, or ventilator care. - Ensure patient acuity aligns with available nursing competencies. Care Coordination & Collaboration - Coordinate with the Clinical Manager and care teams regarding care coordination meetings, high-risk patient discussions, and the escalation of clinical concerns. - Provide clear clinical handoffs to field nurses, schedulers, and care teams. Hospital & Referral Partner Communication - Serve as a primary clinical contact for hospitals and skilled nursing facilities. - Send reports and updates regarding admissions, care delays, and discharge planning when required. - Maintain accurate reporting records and documentation. Patient Tuck-In Calls & Readmission Prevention - Conduct weekly tuck-in calls every Thursday and Friday to check patient status before the weekend. - Identify red flags such as symptom changes, medication issues, wound concerns, or caregiver challenges. - Escalate concerns that may require weekend nursing visits, therapy intervention, physician communication, or care plan adjustments. - Document findings to support proactive readmission prevention. EHR System: - Kinnser