Clinical Research Director jobs in Hialeah, FL

The Research Site Manager is responsible for directly overseeing day-to-day clinical operations at Miami Lakes Medical Research, including organization and implementation of all aspects of daily clinical research functions. Daily functions include but are not limited to, ensuring optimal project/trial conduct of early and later phase studies, maintaining protocol compliance, meeting clinical data quality standards, optimizing operational flow and continuous monitoring/oversight of clinical trial operations. The Research Site Manager will provide formal management and supervision of all research personnel, oversee goal performance and physical space management high-quality relationship management for staff, subjects, sponsors and CROs and all internal team professionals.

Essential Job Duties:

Personnel

• The Research Site Manager will directly oversee the Inpatient Site Lead at MLMR, Clinical Research Coordinators, Research Assistants, and Data Entry Staff. Collaborate with the Clinical Rater Supervisor, Nursing Manager, Principal Investigators, Lead Sub-Investigator, Admissions and Unit Supervisor, and Controller to ensure cohesiveness, quality, and success of the project/trials.

• Expectation of weekly meetings with President and Medical Director to provide a report/update on Nurse Manager, Pharmacy Lead, Unit Manager, Lead Sub-I, Site Lead, Unit Supervisor, Recruitment and Retention teams, Compliance, and New Business.

• Ensure CTMS and data entry compliance for the site.

• Mentor and support direct reports in their responsibilities and functions.

• Assess staffing needs at assigned site according to projections and productivity expectations and communicate needs to Clinical Rater Supervisor, Nursing Manager, Principal Investigators, Lead Sub-Investigator, Admissions and Unit Supervisor, Controller and Human Resources.

• Maintain appropriate staffing levels by flexing existing staff and hiring new staff through either traditional methods or staffing agencies, as required to meet project/trial coverage needs.

• Review applicants resume and conduct initial interviews for all open direct report staff positions, provide recommendations for hire, and document outcomes with Clinical Operations and Human Resources.

• Work with Human Resources, IT Manager, Training and Development team, and Admissions and Unit Supervisor to orient new employees using the new hire checklist process and complete building orientation.

• Oversee the Site Lead’s development of a customized training plan for each new hire according to their historic experience and assigned.

• Lead scheduled departmental meetings with preplanned agenda and corresponding action items.

• Perform probationary and annual performance reviews, setting annual goals and plans for each direct report. Support the Site Lead in the completion of research staff members’ evaluations.

• Meet regularly with each direct report throughout the year to discuss progress on goals and provide timely feedback, including objective, measurable goals.

• Review personnel concerns with the Clinical Operations Team/HR and thoroughly document all personnel issues, as well as any coaching and counseling provided.

• Carry out disciplinary processes as required, providing thorough documentation to the Clinical Operations and HR team.

• Manage relationships and business issues to ensure high morale and low staff turnover rate.

• Work closely with Training and Development team to ensure proper and updated training of MLMR team.

• Collaborate with Department Managers to obtain feedback or recommendations to improve overall site operations and policies.

• Manage staff paid time off, ensure adequate coverage plans for unit at all times, and communicate requests to affected departments and/or personnel (Admissions and Unit Supervisor, Operations).

• Complete biweekly review and approval of payroll for staff under the inpatient umbrella.

Study Conduct

• Collaborate with Medical Director, Clinical Operations & New Business Development to evaluate the feasibility of research projects for MLMR.

• Develop and strengthen operational systems that enhance and improve workflow at MLMR between outpatient and inpatient studies, minimize deviations, and improve the overall site efficiency and functionality

• Create and implement plans for subject, staff, & data flow (including for complex Phase 1 trials) for each study project.

• Develop and refine subject visit flow and subject binders to ensure on time data capture by properly delegated staff for each subject visit

• Manage and track vital project/trial metrics to ensure quality including but not limited to project/trial deviations and violations.

• Manage the site to ensure operational objectives for project/trial are in conformance to all relevant laws, regulations, GCP guidelines, project/trial protocol, and internal SOPs/policies.

• Meet regularly with Inpatient and Outpatient Leads at MLMR to coordinate proper visit flow between outpatient and inpatient studies and foster a collaborative environment between two teams.

• Work closely with Inpatient and Outpatient Site Leads to monitor quality and timeliness of data entry.

• Work closely with applicable parties to maintain proper workflow from admission to discharge for admitted subjects.

• Coordinate with the Admissions and Unit Supervisor in advance of the study start up to ensure we meet all protocol requirements (i.e., special procedures, supplies, vendors).

• Coordinate with the Controller to ensure ordering of proper supplies and development of vendor relationships in advance of study start up.

• Communicate with Segal Trials IT department on all technology-related needs, issues, and problem-solving strategies

• Collaborate with Pharmacy and Nursing Manager to ensure presence of adequate procedures and staffing in advance of study start up.

• Meet with appropriate managers (Medical/Nursing/Rater/Pharmacy/Building) to coordinate staffing and proper coverage for inpatient and outpatient trials, particularly phase-1 projections, (i.e. 24 hours/day, 7 days/week).

• Distribute studies among coordinators, considering the site, coordinator, subject, experience, training & sponsor needs.Ensure completion of study-required training and system accesses are obtained by appropriate staff for new and ongoing studies.

• Ensure completion of other sponsor and site-initiated training as needed and communicate delays to study start-up team.

• Participate in the conduct of PSSVs, SIVs and introduce self to all CROs, Project Managers, CRAs, etc. at the initiation of all trials as a point of contact for escalation and administrative updates.

• Prepare study materials & mock trial runs to ensure successful study procedure completion.

• Provide back-up for appropriate study tasks, as dictated by patient flow and staff coverage.

• Maintain oversight of accurate and efficient data entry into all systems, such as Electronic Data Capture (EDC), Interactive Response Technology (IRT), and Clinical Trial Management (CTMS).

• Support Site lead in conducting CRA visits, including the accurate & timely completion of monitoring follow-up letter action items. Address all patient, vendor and sponsor complaints in a timely and effective manner.

• Participate in QC feedback meetings as needed with QC Analyst, Director of Compliance and Clinical Operations, Director of Regulatory and Quality and Medical Director to strengthen quality and operational systems.

• Facilitate the Quality Control (QC) process, ensuring the accuracy of study data through reviews. Follow provided escalation plan SOP to Clinical Operations and QC, as required.

• Review quality metrics regularly, adjusting operations & training as needed to address concerns.

• Provide regular updates to Recruitment and Clinical Operations Teams on-site needs, trends, and concerns in order to meet study enrollment and census goals.

Goal Performance

• Track and oversee enrollment progress and assess needs for meeting site and study goals and build study plans that ensure success

• Review study enrollment performance metrics weekly and ensure accuracy of data.

• Attend regular meetings to review recruitment needs and to analyze progress on goals

• Manage the sites’ operations and staffing to be able to meet and exceed enrollment in multiple clinical trials at same time while ensuring quality of data

• Coordinate with Clinical Operations and Business Development to ensure that the sponsor’s goals, timelines, cost, and quality performance are met in the conduct of all projects/trials

• Collaborate with study startup team to ensure all timelines and deliverables are met in accordance with requirements, including complex Phase 1 trials. Escalate delays to Clinical Operations and Medical Director.

• Provide support and leadership to site staff to ensure professional growth for direct reports and job performance goals are met

• Maintain oversight of revenue efficiency at the site and provide recommendations to maximize Return Of Investment and improve budgetary expenses.

• Review site contracts and budgets to broaden understanding of how to compensate for delays/study closures/etc. and disseminate expectations/updates to the study team

• Utilize Study performance goals provided by the business office; disseminate and monitor these goals/expectations at MLMR.

• Manage threats and risks to the site and implement procedures to address systemic concerns; including but not limited to risks to business operations and success, recruitment, study conduct, and staffing.

• Ensure follow-up for issues affecting reimbursement or collection delays, denials, issues, etc., and communicate progress to the Accounts Receivable team.

• Ensure appropriate use of credit cards and petty cash, providing receipts for reconciliation.

• Collaborate with other departments as necessary to successfully meet study and site targets.

• Participate in annual SOP review and assist in developing/updating SOPs as needed.

• Assist with project/trial and site audits.

Physical Space Management

• Work directly with Admissions and Unit Supervisor and Controller to manage all required vendors for the successful performance of clinical trials in free-standing and/or embedded units (i.e., pest management, laundry services, catering, security, etc.).

• Ensure minimum standards are met and maintained for all relevant regulatory bodies at MLMR and escalate any issues to appropriate managers.

• Collaborate with the Admissions and Unit Supervisor in order to schedule adequate staffing to meet minimum safety needs for subjects, staff, and clients.

• Work directly with Admissions and Unit Supervisor and Controller to maintain physical space, ensuring safety and attractiveness for subjects, staff, and clients.

• Oversee response teams for time-sensitive space issues, such as temperature management and implementation of emergency preparedness SOPs.

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Report to duty at physical locations other than the primary assigned location(s) on an as-needed basis. The fluctuating nature of the industry and the existence of multiple physical business addresses mean that employees must be prepared to adjust work location within reason as dictated by business needs.

OTHER SKILLS AND ABILITIES:

• Possesses strong organizational skills

• Able to prioritize, delegate, direct, support, assign and evaluate others’ work.

• Follows through on assignments and ability to meet time-sensitive deadlines

• Operationally focused, with a strong systems approach to solving challenges

• Able to work independently with a high degree of autonomy and reliability

• Functions well in a high-pressure environment.

• Possesses excellent communication skills.

• Exhibits strong verbal and written communication skills through positive interactions with coworkers, managers, clients and vendors.

• Displays team building and collaboration skills

• Works effectively and collaboratively with team members to accomplish goals

• Able to provide strong leadership to a multidisciplinary group with a focus on professional development and goal attainment

• Curious and passionate about learning and innovation

• Displays initiative for continued growth

• Skilled at thoughtful risk-taking to accomplish tasks.

• Able to balance tasks with competing priorities.

• Able to accept direction and constructive criticism from supervisors and managers.

REQUIREMENTS:

• Minimum 5 years of relevant Clinical Research experience

• Early phase clinical research coordinating/experience, a must.

• 3 years of work on psychiatric protocols, or equivalent research experience

• Requires thorough knowledge of the drug development process; clinical trial management; clinical monitoring and FDA regulations and ICH Guidelines

• 5 years of management or team leadership experience

• Proficiency in English required.

• Proficiency in English and Spanish is preferred.

• Familiarity with Microsoft Office, including Outlook and Excel.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• Miami Lakes, FL 33016: Relocate before starting work (Required)

Work Location: In person