We are currently searching for a skilled professional to join a well-known client's team as a Clinical Operations Associate in Aliso Viejo, California. The Clinical Operations Associate role will execute assigned clinical operations activities in support of study conduct throughout the study lifecycle and ensure quality execution and compliance with all required policies and procedures for assigned tasks. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
Manage the (e)Trial Master File and essential documents
Process and execute contracts
Facilitate Investigator and Study registration updates
Assist in the development and QC of Informed Consent and other study specific documents
Develop processes and controlled documents
Facilitate Clinical Document Change Request, Risk Assessment, and Quality Management System activities
Oversee HCP/HCO clinical engagement activities per company policies and procedures
Support clinical audit activities
Participate in the development, review, implementation, and updating of key standard processes that lead to positive and measurable impact for clinical programs managed by the clinical research team
Lead management of clinical systems updates, enhancements, and master data stewardship
Coordinate activities across clinical teams for the completion and continued execution of process improvement and compliance related initiatives
Track and report Key Performance Indicators (KPIs) and metrics for quality oversight of applicable clinical operations-related activities
Interact with internal and external stakeholders related to study conduct
EXPERIENCE
Minimum of 2 years of related experience preferred
Knowledge of ICH/GCP, local regulatory authority drug research and development regulations, and clinical trial operations required
Experience in clinical trials support or pharmaceutical industry required
Strong planning, organizational, analytical, time management, conflict management, and problem-solving skills
Excellent written, verbal, and interpersonal communication skills
Ability to work in a fast-paced environment and adjust workload based on changing priorities
Experience with PC-Windows, word processing, and electronic spreadsheets required
Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)
Travel requiredto carry out responsibilities
EDUCATION
Minimum of Bachelor's Degree or equivalent in a scientific or health care field required
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
