RCM Technologies Clinical Operations Coordinator in Danvers, Massachusetts
RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. Our client is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives . With corporate headquarters in Danvers, Massachusetts, and offices in Baltimore, MD, Woburn, MA, Aachen & Berlin, Germany and Tokyo, Japan, with 2,000 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development. Patients First | Innovation | Winning Culture | Heart Recovery Job Description: The Clinical Operations Coordinator is responsible for supporting efforts to effectively onboard new hires, ensure associates have access to and receive training to perform their assigned responsibilities, contribute to business process improvement and technology implementation/refinement initiatives, and provide routine support to the Clinical Operations and Compliance functions to conduct highly efficient and quality focused clinical trial execution. Primary Duties and Responsibilities:
Executes continuous activities to ensure ongoing health authority inspection readiness including but not limited to the following:
Management of role-based Training Plans/Curricula for internal and external study team members and leadership
Job Descriptions and Curriculum Vitae (CVs) are current, signed, and centrally stored
Training records are complete, accessible, and can be readily retrieved
Organization Chart is current and reflects appropriate titles
Maintains ongoing updates to the Quality System by ensuring Standard Operating Procedures (SOPs) are reviewed annually and updated if applicable. Follows established change control procedures to update and submit SOPs for formal revision and approval.
Drives departmental onboarding of new associates to ensure they receive appropriate training and are effectively integrated into the organization and study team(s) they will support.
Supports Manager of Compliance with internal/external audits and quality reviews
Supports quality control review of clinical and regulatory documents to ensure consistent references, formatting, change control, branding, etc.
Assists with gathering business end user process requirements to support technology implementation/refinement activities.
Assists clinical trainers with managing training materials and gathering training completion logs.
Supports the development of job aides/training materials including business process mapping visualizations.
May support clinical study site payment tracking and reconciliation efforts as requested by leadership.
Assist with the design and application of assessment tools to measure training effectiveness.
Track and report on training compliance to clinical management.
Evaluate and make recommendations regarding training material and methodology.
Manage and coordinate logistics for internal training activities including venues and equipment, as necessary.
Coordinate requests for clinical system access.
Maintains accurate and complete study records.
Ability to perform additional responsibilities as requested.
Bachelor's degree from an accredited university required; Preference will be given to candidates/individuals with a Bachelor of Science (BS) degree in Life Sciences or related medical/scientific/technical.
Minimum 2 years of professional experience in a CRO, pharmaceutical, biotechnology, or medical device company.
Familiarity with clinical trial operations, ICH, GCP Guidelines and other applicable Regulatory requirements .
Good working experience in a team environment across multi-functional areas.
Highly organized, self-motivated, detail-oriented, proactive, and accurate .
Ability to work with urgency and thrive in a high-energy, fast-paced environment.
Demonstrate excellent communication, verbal and written, and interpersonal skills .
Demonstrate advanced proficiency in MS Office Suite: Word, PowerPoint, Excel.
High attention to details and accuracy; ability to work independently and to prioritize and organize work to meet deadlines.
Proactive and dedicated to continuous improvement.
Experience coordinating Clinical Training Programs and working with Clinical Training Systems strongly preferred.
Ability to travel 10%.
RCM Technologies, (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCM encourages applicants of all ages. #Monster