OverviewThe Manager of Clinical Research Operations reports to the Sr. Director of Clinical Research Operations and provides leadership, day-to-day management and general oversight of the organization’s clinical research trial activities and staff. The manager is responsible for the execution and success of clinical research operations to ensure organization defined goals are met and exceeded according to research trial contractual terms. Part of the role is also to make sure the team follows principles of Good Clinical Practice (GCP)/International Harmonization Conference (ICH), Health Insurance Portability and Accountability Act (HIPAA), Federal Drug Administration (FDA) policies and guidelines, and other applicable regulations (state and local). The Manager is responsible to make sure the team is in compliance, as well as all parties following all company policies and labor laws. The Manager may also be responsible for developing and implementing strategies to recruit candidates from diverse communities to align to the objectives of the organization’s mission to reduce health inequality and stigma and expand our research programs. Essential Functions and Responsibilities (This list may not include all the duties assigned.) - Act as sponsor point-of-contact for sites.
- Prepare and coordinate weekly team meetings.
- Supervise and provide leadership to clinical research coordinators and ancillary staff as directed by the Sr. Director of Clinical Research.
- Assist Clinical Research Team in hiring, on-boarding, training, and evaluating clinical
research staff. - Conduct protocol-specific on-boarding, training, and evaluation for clinical research staff.
- Monitor and work with staff to ensure adherence and fidelity to study protocols.
- Proactively communicate with and respond to requests from trial sponsors and monitors.
- Ensure research clinic is fully operational and staffed appropriately for clinical trials.
- Work cross-functionally to handle matters related to regulatory management.
- Coordinate with external vendors that support research and facility operations.
- Implement and monitor safety and social distancing protocols, ensuring staff and patients adhere to infection control policies and procedures.
- Strengthen community engagement in research activities across the MHF network using principles of Community-based Participatory Research (CBPR) as a guiding framework.
- Implement outreach and recruitment activities to achieve diversity enrollment goals.
- Attend community meetings and events as appropriate to raise awareness of MHF and the organization’s research program.
- Participate in sponsor monitoring visits as requested by the Principal Investigator, Sub- Investigator(s), and/or Sr. Director of Clinical Research Operations, preparing case report forms and collecting source documents for sponsor / audit review and ensuring quality metrics are met.
- Meet with research team during routine visits to discuss case report form completion, query resolution and other protocol-related issues and prepare for and participating in FDA inspections.
- Lead efforts to expand access to research and clinical trials across the MHF network.
- Participate in efforts to expand MHFs research program to include social and behavioral research on issues relevant to our patient populations.
- Collaborate with MHF programmatic staff to develop robust strategies for data collection, analysis, and program evaluation to support MHFs efforts to secure funding and develop, implement, and replicate innovative evidence-based programming.
- In a timely manner completes the submission of all documents to the IRB required for the initial application of new studies and the annual renewal of current studies.
- Completes in a timely manner, the collections and submissions of FDA Form 1572, Financial Disclosures, Protocol Signature Page, Investigational Brochure and other documents required for study start up.
- Communicates routinely to the research staff about protocol updates and regulatory changes by updating the CTMS or by other appropriate methods.
- Reviews research studies offered by appropriate sources to help determine if studies are consistent with the department’s goals / objectives and patient population.
- Actively participates in the development, implementation, monitoring, and regulatory oversight of high-quality research within the department.
- Familiarity with clinical trials operations, finance, budgets, contracting and billing.
- Provides ongoing education and updates to physicians, nurses and other health professionals regarding protocol activities, including subject eligibility criteria, updates on new studies, amendments, closures, and other guidance.
- Maintains records (e.g., training certification, CVs, etc.) according to established department policies, procedures, and sponsor requirements. Participates in the development, review, and maintenance of clinical research policies and standard operating procedures (SOPS).
- Adhering to HIPAA requirements when transmitting data via fax, mail, or electronically as requested by the sponsor or CRO, and resolving data queries and maintaining files for all study related documentation.
- Providing quality assurance on variety of office functions and research operations related to clinical trials, including completion and maintenance of all study drug accountability records, including drug dispensing and returned drug compliance and findings.
- Completing all required data entry and attending to query resolutions in the allotted time per sponsor, protocol, FDA and GCP guidelines.
- Other duties may be assigned as required.
QUALIFICATIONS: - Bachelor's degree in a scientific discipline preferred or equivalent experience. (Master’s degree in public health preferred).
- CCRP certification preferred.
- At least 5-10 years’ clinical research experience.
- Experience managing and supervising interdisciplinary teams, collaborate cross- departmentally, engaging with stakeholder’s, executive-level staff and relate well to people.
- Demonstrated ability to multi-task and manage several projects in parallel, paying attention to detail.
- Strong project planning, leadership and presentation skills.
- Skills and knowledge related to program planning, implementation and evaluation.
- Quantitative and qualitative data collection, analysis, and interpretation skills.
- Knowledge of regulatory compliance i.e., GCP, HIPPA, OSHA, IATA, COLA, CLIA, etc.
- Willingness to work flexible hours to meet the organization’s needs/demands.
SKILLS AND COMPETENCIES: - Must have excellent interpersonal skills and empathy towards patients, as well as have excellent communication skills, critical thinking skills, and the ability to handle stressful situations.
- Must have the capacity to function independently, have varied clinical research experience, and the ability to document meticulously.
- Must have excellent process improvement skills and be able to understand research functions and department interactions.
- Knowledge of research management components, particularly in a highly regulated scientific setting.
- Knowledge of regulatory compliance i.e., GCP, HIPPA, OSHA, IATA, COLA, CLIA, etc.
- Ability to manage and supervise various positions and relate well to people.
- Basic understanding of information technology and ability to organize, analyze and synthesize complex data from various sources.
- Able to read and interpret financial statements, develop and nurture vendor relationships for purchasing optimization.
- Willingness to work flexible hours in order to meet the organization’s needs/demands.
- Bilingual a plus.
COMPANY REQUIREMENTS - Must be able to pass a pre-employment drug test, physical, and a background check to include a 7-year criminal, 10-year SSN & employer history reference check.
- Must be able to provide proof of COVID-19 vaccination on the first day of work.
- Excellent interpersonal skills.
- Attention to detail.
- Must be able to work flexible schedules.
- Must take yearly flu shots or wear flu mask during flu season for patient-facing positions and test for tuberculosis as required by the Centers for Disease Control and Prevention.
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