• Performs and coordinates all aspects of the clinical monitoring and site management process. • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. • Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. • Ensures audit readiness. • Develops collaborative relationships with investigational sites. • Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. • Assesses investigational product through physical inventory and records review. • Documents observations in reports and letters in a timely manner using approved business writing standards. • Brings up observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. • May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. • Conducts monitoring tasks in accordance with the approved monitoring plan. • Participates in the investigator payment process. • Ensures a shared responsibility with other project team members on issues/findings resolution. • Investigates and follows-up on findings as applicable. • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. • Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). • Performs QC check of reports generated from CTMS system where required. • Participates in investigator meetings as necessary. • Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. • Ensures trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. • Conducts on-site file reviews as per project specifications.

• Conduct pre-market and post-market clinical studies to ensure regulatory compliance • Manage site start-up and activation processes • Perform site monitoring visits and maintain clinical study data • Serve as primary liaison for clinical trial sites and ensure data accuracy

Title: Telehealth Psychologist (Chinese Speaker) Location: Remote Remote CN Job Description: OOCA, a fast-growing Mental Health Care company, is looking for a skilled Telehealth Psychologist to join their team. The ideal candidate should have a passion for helping patients in need of mental health services and the ability to provide care remotely via phone and video. As a Telehealth Psychologist, you will work collaboratively with the care team to provide personalized care and develop treatment plans for patients. You will have access to advanced telemedicine technology to offer high-quality services and ensure patient privacy and confidentiality. The role also offers opportunities for professional growth, education, and research. Responsibilities - Conduct initial patient assessments and develop personalized treatment plans - Provide evidence-based, patient-focused psychological interventions remotely - Collaborate with other members of the care team to deliver interdisciplinary care - Maintain accurate patient records and ensure confidentiality of patient information - Participate in peer consultation and supervision meetings - Continuously update knowledge and skills in the field of Telehealth psychology - Participate in company-sponsored conferences, workshops and training sessions Requirements - Chinese Native Speaker or Level HSK4 - Doctorate degree in Counseling Psychology or related field - Active state licensure as a Psychologist - Minimum of 2 years experience in providing Telehealth Psychological services - Demonstrated ability to provide evidence-based psychological interventions remotely - Familiarity with assessment tools, including cognitive, personality, and diagnostic measures - Strong communication and interpersonal skills to build rapport with patients from diverse backgrounds - Ability to work collaboratively with a team and independently as needed. Benefits - Work from anywhere - Flexible schedule - Incremental revenue

• Act as Parexel’s direct contact with assigned sites • Build relationships with investigators and site staff • Facilitate and support site with access to relevant study systems • Perform on-site visits and remote visits • Ensure timely and accurate completion of project goals