Job Summary:The Manager, Site Operations is responsible for managing the clinical operations staff, training and onboarding of new staff, managing quality and compliance of clinical Work closely with and in support of the Site Director. Able to perform coordinator as well as supervisor duties and fill in during the absence of site coordinators. Able to function as lead coordinator on select protocols. Must be able to work independently and with all staff and customer levels.
ResponsibilitiesDuties/Responsibilities:- Work with the Site Director to meet/exceed the site's financial, operational and study-specific targets.
- Support the identification of strategies to expand the research capabilities at the site - in line with the overall site business plan.
- Support the implementation and maintenance of VCR quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs.
- Work with the Site Director to address any study and/or clinical quality related matters.
- Ensure timely and appropriate communications occur with Sponsors and IRBs as necessary.
- Support the development of site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies.
- Support or lead the development of the patient recruitment plan and patient outreach process for studies. Make ongoing adjustments/modifications to recruitment strategies based upon the timely review of results to ensure study-specific targets are being met.
- Manage the performance of site staff members, delegating appropriate and challenging assignments to encourage growth, development and responsibility. Responsible for supporting the ongoing training needs of site staff members are met.
- Communicate performance expectations and guidelines to site staff members.
- Identify and manage issues, concerns and problems related to staff conduct and performance.
- Identify and build relationships with outside medical practices, pharmacies, and other healthcare professionals/organizations to aid in the patient recruitment process.
- Support business development activities on behalf of the site and VCR with sponsors, CROs,CRAs and any third-party study vendors, as appropriate.
- Share best practices with other VCR site locations with the goal of raising the overall level of operational competencies at VCR.
- Support the completeness, accuracy and timeliness of Feasibility Questionnaires, CDAs, CVs and essential regulatory documents from study start-up phase until site initiation.
- Attend industry and VCR meetings relevant to the position of Manager, Site Operations.
- Manage facility and IT needs to ensure smooth and efficient operations
- Other duties as assigned
QualificationsRequired Skills/Abilities:- Expertise in project management
- Knowledge of field organizational strategies
- Extensive knowledge of clinical research
- Strong communication and presentation skills
- Able to generate business correspondence, create forms and generate reports as required
- Practices professionalism and integrity in all actions
- Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
- Ability to communicate effectively in English (both verbal and written)
- Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
- Other duties as assigned
Education and Experience:- Bachelor's degree preferred; Advanced degree suggested or equivalent clinical research experience.
- 5+ years of clinical management experience or equivalent applicable experience in clinical research industry
Physical Requirements:- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management
