Clinical Research Manager

Urology San Antonio; San Antonio (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Urology San Antonio is seeking a Clinical Research Manager to support the daily activities of the research team. You will supervise a diverse staff and ensure projects are completed on time and in compliance with standards, reporting to the Director of Research and principal investigators.

The role requires coordinating site visits, managing data integrity, and assisting with recruitment strategies to meet enrollment goals across multiple studies.

Qualifications

• Bachelor-level degree in sciences or equivalent.
• At least 3 years of clinical research experience.
• Supervisor experience of a project or team is required.
• Nursing or medical degree is preferred.
• Must be HIPAA compliant.
• Clinical Research Certification is a plus.

Responsibilities

• Supervise staff including Study Coordinators,Recruiters, Lab Techs and Data Coordinators.
• Ensure compliance with SOPs, FDA CFRs and ICH guidelines.
• Coordinate site visits and sponsor communications.
• Oversee enrollment, training, and performance reviews.
• Manage data collection, CRFs and data queries.
• Support recruitment strategies to meet enrollment targets.

Skills

Staff supervision

SOP compliance

Regulatory knowledge

Attention to detail

Communication skills

Multitasking

Microsoft Office

Education

College degree in sciences

3+ years clinical research experience

3+ years supervisor experience

Nursing or medical degree preferred

HIPAA compliance

Clinical Research Certification

Tools

CRFs (paper & electronic)

EDA/Data management tools

Microsoft Office

Job description

JOB SUMMARY The Clinical Research Manager CRM is responsible for supporting the daily activities of Research team members to ensure all projects are completed on time and in compliance with all standards In addition the CRM manages the team comprised of various roles and serves as an important knowledge resource in their department The CRM will work directly under the Director of Research and the principal investigator on various studies

DUTIES AND ESSENTIAL JOB FUNCTIONS

Supervises staff classified as Study Coordinator I IIIRecruiter ScreenerLab TechnicianData Entry Coordinators Adheres to compliance activities including but not limited to Standard Operating ProceduresAccepted Clinical Practices Current regulations and guidelines associated withLocal State & Federal lawFood & Drug Administration FDA Code of Federal Regulations CFR The International Conference on Harmonization ICHInstitutional Review Board IRB Manages Administrative functions Perform a variety of administrative duties requiring a high level of knowledge of study specific protocolsParticipate in staff hiring and schedule training Train other Clinical Research Study Team members Oversee day to day study related responsibilities which may vary with each clinical trialSupervise research staff and ensure that they are reviewed regularly remain relevant and adhere to policy and proceduresAssist Director of Research in developing strategies for recruitment as appropriate to meet or exceed target enrollmentsDistribute and coordinate work assignments Review study protocol with the Research coordinators data coordinators and investigators and ensure everyone is aware of their roles and responsibilitiesEvaluate staff performance Interacts with Sponsors and related representatives to Initiates the conversation with the Clinical Research Associate who works for the Contract Research Organization employed by the sponsorParticipate in the Site Qualification Visit Interim Monitoring Visit Site Initiation Visit and Close Out VisitServe as the main point of contact after the Site Initiation Visit SIV for all monitoring activitiesInitiate scheduling of participant clinic visits and ongoing study visitsAttend participant visits as needed to ensure clinical procedures lab tests and other protocol specific activities are completed as outlined in the protocolsInstruct subjects in protocol procedures medication compliance concomitant medications accurate diary maintenance self rating scales and schedule of events Provide close oversight and review of data collection data entry as well as protection of data integrity for all studies assigned to the research teamProvide quality control review of subjectpatient charts prior to randomization or screen fail to ensure accuracy of status determinationMonitor enrollment and provide enrollment updates for the clinical team and sponsorsServe as point of contact to clinical research staff patient navigators and sponsors for study specific information Supervise timely and accurate transcription of information on source documents paper Case Report Forms CRFs and electronic CRFsRespond to data queries and other requests from data coordinators and study monitors in a timely manner Provide backup for other Clinical Research Coordinators and Data coordinators as needed Interface with Clinical Research Associate and company personnel assigned to the studyPrepare for monitoring visits to ensure the necessary information is available to the monitor andAccompany the monitor during monitoring visits Organizes Evaluation Criteria Specific metrics relating to meeting enrollment goalsProficiency in managing compliance with study guidelines Quality Control Metrics including measures such as a low rate of return for clarifying questions from the Contract Research Organization CRO

Other functions and Responsibilities

Other functions and Responsibilities This job description does not cover or contain a comprehensive listing of activities duties or responsibilities required for this job In addition duties responsibilities and activities may change at any time with or without notice

COMPETENCIES

Patient & Customer FocusEthical Conduct Flexibility InitiativePersonal EffectivenessCredibilityStress ManagementComposureStress ManagementComposure High attention to detail and strong organizational skillsExcellent written and verbal communication skillsAbility to work well independentlyMaintain confidentialityExperience with Microsoft Office Suite Outlook Word Excel PowerPointPossess strong skills for multitasking meeting competing deadlines prioritizing and supporting PIs for multiple projects

QUALIFICATIONS

Required College Degree in the field of sciences3 years or more Clinical Research experience3 years or more Supervisor experience Preferred Nursing or Medical DegreeHIPAA complianceBilingualSpanishClinical Research Certification