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

•\tSupervise 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).

•\tMaintain the necessary infrastructure (i.e., human resources, rooms and beds, equipment, partners, suppliers) for conducting clinical trials at the respective unit.

•\tContinuously maintain and improve the highest quality standards, practices, and excellent working relationships with customers, authorities, third parties and team members.

•\tCoordinate all clinical trial activities at the unit in compliance with trial protocols and ensure timelines are met.

•\tAssume overall project management as needed.

•\tAssess training needs for ARENSIA personnel at the unit and makes recommendation to Regional Executive Director.

•\tEnsure that clinic areas are clean, properly set-up and clinic equipment are operational.

•\tAssist with the development and implementation of SOPs.

•\tPerform internal quality and compliance checks and report observations to Regional Executive Director.

•\tRespond in a timely manner and ensure required actions are taken.

•\tLead clinical trial feasibilities (along with Regional Medical Director, Regional Executive Director and Country Manager), as requested.

•\tAttend internal meetings and visits conducted by industry sponsor and/or CRO (including Study- Initiation Visits, Qualification Visits, Kick-off Meetings, etc.).

•\tCommunicate with third party vendors as needed.

•\tSupervise and support site staff, providing guidance and training as needed.

•\tConduct regular performance evaluations and identify training needs.

•\tPromote a positive and collaborative work environment.

•\tParticipate in meetings with clients and advise clients if requested.

•\tOversee timely data collection, entry and reporting.

•\tResolve data queries and discrepancies.

•\tEnsure the integrity and confidentiality of data.

•\tPrepare for and facilitate regulatory inspections, audits and other types of visits.

•\tRespond to audit reports and implement Corrective and Preventive Actions (CAPAs) following respective trial audits.

•\tAssist in the development and implementation of patient recruitment strategies to meet enrolment targets.

•\tRecruit patients and coordinate the recruitment team.

•\tMonitor patient recruitment progress and implement corrective actions as needed.

•\tMaintain high standards of patient care and communication.

•\tOther duties as assigned.

Skills

Phase I, Oncology, Early Phase, First in Patient

Additional Skills & Qualifications

Knowledge, Skills and Abilities-Required

•\tKnowledge of local legal requirements/laws and ICH GCP guidelines for the conduct of clinical trials.

•\t Understanding of the pharmaceutical and biotechnological industry and the services provided by ARENSIA.

•\tSolid understanding of the different types of trials and investigational drugs.

•\tPrior experience in conducting clinical trials and QA/QC.

•\tAbility to lead a team: envision, engage, enable, execute, energize.

•\tExtraordinarily well-organized and capable of planning activities in advance, as well as managing the interaction between client's needs and internal team processes.

•\tExcellent communication skills, especially in dealing with Sponsor representatives, IRB, and ARENSIA trial team members.

•\tFluent oral and written English language.

•\t 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.

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