Job Information
Actalent Research Clinic Operation Lead (Phase I) ONSITE in Phoenix, Arizona
Seeking a Sr. Research Coordinator or Manager for ONSITE Clinical Supervisor Role.
Must have experience running clinic operations in Early-Phase/First-In-Human studies.
Oncology experience would be a huge plus
Direct placement.
Screening applicants immediately.
Description
Research Clinic Operational Lead is the clinical operational lead of the research clinic and the person responsible for all day-to-day clinical trial activities of the unit, except for individual projects the Principal Investigator is medically responsible for.
Main Responsibilities
• Supervise the conduct of clinical trials according to the highest medical and scientific standards (in accordance with EU Regulations, ICH-GCP Guidelines, SOPs and local regulations).
• Maintain the necessary infrastructure (i.e., human resources, rooms and beds, equipment, partners, suppliers) for conducting clinical trials at the respective unit.
• Continuously maintain and improve the highest quality standards, practices, and excellent working relationships with customers, authorities, third parties and team members.
• Coordinate all clinical trial activities at the unit in compliance with trial protocols and ensure timelines are met.
• Assume overall project management as needed.
• Assess training needs for ARENSIA personnel at the unit and makes recommendation to Regional Executive Director.
• Ensure that clinic areas are clean, properly set-up and clinic equipment are operational.
• Assist with the development and implementation of SOPs.
• Perform internal quality and compliance checks and report observations to Regional Executive Director.
• Respond in a timely manner and ensure required actions are taken.
• Lead clinical trial feasibilities (along with Regional Medical Director, Regional Executive Director and Country Manager), as requested.
• Attend internal meetings and visits conducted by industry sponsor and/or CRO (including Study- Initiation Visits, Qualification Visits, Kick-off Meetings, etc.).
• Communicate with third party vendors as needed.
• Supervise and support site staff, providing guidance and training as needed.
• Conduct regular performance evaluations and identify training needs.
• Promote a positive and collaborative work environment.
• Participate in meetings with clients and advise clients if requested.
• Oversee timely data collection, entry and reporting.
• Resolve data queries and discrepancies.
• Ensure the integrity and confidentiality of data.
• Prepare for and facilitate regulatory inspections, audits and other types of visits.
• Respond to audit reports and implement Corrective and Preventive Actions (CAPAs) following respective trial audits.
• Assist in the development and implementation of patient recruitment strategies to meet enrolment targets.
• Recruit patients and coordinate the recruitment team.
• Monitor patient recruitment progress and implement corrective actions as needed.
• Maintain high standards of patient care and communication.
• Other duties as assigned.
Skills
Phase I, Oncology, Early Phase, First in Patient
Additional Skills & Qualifications
Knowledge, Skills and Abilities-Required
• Knowledge of local legal requirements/laws and ICH GCP guidelines for the conduct of clinical trials.
• Understanding of the pharmaceutical and biotechnological industry and the services provided by ARENSIA.
• Solid understanding of the different types of trials and investigational drugs.
• Prior experience in conducting clinical trials and QA/QC.
• Ability to lead a team: envision, engage, enable, execute, energize.
• Extraordinarily well-organized and capable of planning activities in advance, as well as managing the interaction between client's needs and internal team processes.
• Excellent communication skills, especially in dealing with Sponsor representatives, IRB, and ARENSIA trial team members.
• Fluent oral and written English language.
• Knowledge of MS Office.
Experience Level
Intermediate Leve
Pay and Benefits
The pay range for this position is $60000.00 - $85000.00/yr.
Benefits. Benefits. Benefits. Benefits. Benefits. Benefits. Benefits. Benefits. Benefits. Benefits.
Workplace Type
This is a fully onsite position in Phoenix,AZ.
Application Deadline
This position is anticipated to close on Mar 9, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.