Allied Health jobs in California

SUMMARY/JOB PURPOSE: The Clinical Trials Manager (CTM), Clinical Operations, coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL). ESSENTIAL DUTIES AND RESPONSIBILITIES: * Manages clinical trials, including those conducted through Contract Research Organizations (CROs) * May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams * Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab) * Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight * Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. * Attends and contributes to internal Study Delivery Team (SDT) meetings, including contribution to agenda preparation * Coordinates the preparation, conduct, and presentations at Investigator Meetings * Assists Study Delivery Team (SDT) and CRO in feasibility assessments and site selection * Assists with study protocol development, reviewing of informed consent forms, case report forms, monitoring plans, and other study materials * Maintains regular contact with relevant departments (e.g., Regulatory Affairs, Drug Safety, Clinical Supplies, Data Management, etc.) * Provides oversight to CRO to ensure site adherence to protocol and Good Clinical Practice (GCP) guidelines * Proactively identifies and communicates study issues, provides risk mitigation strategies, and escalates issues as needed * Provides support for adherence/compliance to study plans (e.g., Verification of Performance (VOP) * Ensures oversight of regulatory and essential documents * Supports and oversees the development of study plans and documents (e.g., VOP, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) * Coordinates the design, format, and content of study guides and subject instructions * May participate in strategic governance discussions as required (e.g., SAB, BOD, DT, TAT, DSC, DOC) * May support / be responsible for site and vendor invoice reviews * Reviews and provides oversight of study trackers and metrics * Provides oversight to development and review of study documents (i.e. Protocol, ICF, CRFs, IRT specifications, Inv product labels, etc) * May be responsible for department strategic initiatives or process improvements * May serve as a mentor and provide training to Sr. Clinical Trial Specialists (CTS) SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * BA/BA/BSN in biological sciences or related field and a minimum of 7 years of related experience; or, * MS/MA/MSN in biological sciences or related field and a minimum of 5 years of related experience; or, * PhD/PharmD in biological sciences or related field and zero or more years of related experience; or, * Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: * Typically requires a minimum of 7 years of related experience in life sciences, including 5 years in experience in clinical research Knowledge/Skills: * Experience in either starting a study up, maintenance phase, or study close-out * Experience with development of prospective site-selection criteria * Protocol development experience * Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures * Familiar with advanced concepts of clinical research * Ability to deal

Job Description Our FSP team is currently seeking a CRA 2 in California with 2 years of monitoring! May consider other West Coast states. 8-10 days on site per month being a mix of onsite and remote. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities : Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - Responsible for all aspects of site management as prescribed in the project plans General On-Site Monitoring Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management Assist with training of new employees, eg. co-monitoring Coordinate designated clinical projects as a Local Project Coordinator (with supervision, ifapplicable) and may act as a local client contact as assigned Perform other duties as assigned by management Requirements University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) 2 years of Clinical Monitoring experience 60% overnight travel The important thing for us is you are comfortable working in an environment that is: Fast paced : where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. Changing priorities constantly asking you to prioritize and adapt on the spot. Teamwork and people skills are essential for the study to run smoothly. Technology based . We collect our data directly into an electronic environment. Work Environment: Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: Ability to sit for extended periods and operate a vehicle safely. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Target Pay Range: $100-112K #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.