Clinical Research Operations Manager

SUMMARY:

Under the general direction of theDirector HumanResearch Protection Program (HRPP) the Clinical ResearchOperationsManager supports the day-to-day operations of approximately eight clinical research staffand facilitates the identification and implementation ofpotentialclinical trials and other research activitieswithin the Saint Alphonsus Health System.Will act as a liaison between the clinical research teams and Director HRPP to ensure regulatory and institutional complianceas well as thepreservationof human subject protections throughout the continuum of the research. Will participate in a variety of complex activities involvingstaff recruitment and trainingstaff developmentteam member performance activities clinical trialbudget negotiationSOP maintenanceandleadership representationfor external vendors CROs and trial sponsors.

Will assume responsibility foralldailyclinic trialoperations andthemanagement ofclinicalresearchstaff.Additionally exceptional administrative project managementleadershipand communication skillsto develop and maintainacademic and industrypartnerships.Supports and maintains a positiveworking environment and sets an expectation for adherence to the Trinity Health Core Values.

The Clinical Research Operations Managerserves as the primaryclinicalresearch contactinthe regionfor internal and external parties.Functions as a mentor trainer and supporter tonew and existing research coordinators. Serves as a coach and a consultant to less experienced employees.Oversees the training of newly hired research staff.SupportsDirector HRPPinstaffrecruitmentandretention.

HOURS: Traditional daytime hours.

REQUIREMENTS:

• Must possess knowledge normally acquired through completion of a Bachelors degree innursing biology or health sciencesor equivalent combination of education and experience.

• Minimum of10years in clinical research experienceis required with emphasis on prospective randomized Phase 2-4 trialsinvestigator-initiated proposals andteam developmentand management.

• Proven ability tomanage multipleprojects and tasksand adhere to requestedtimelines.

• Recent experience in a clinical patient care setting with demonstrated proficiency in medical terminology and EMR navigation required.

• Certification with Association of Clinical Research Professionals (ACRP) or CRPC (Clinical Research Professional Certification) with Society of Clinical Research Association (SOCRA) preferred.

• Additional certifications and/or trainings in program management leadership etc. are preferred.

WHAT YOU WILL DO:

• Meets Health Systems Guiding Behaviors and Caring Standards including interpersonal communication and professional conduct expectations.

• Facilitatesand supportsthe clinical teamswhenconducting feasibilityassessments giving insight and feedback related tovarious operationalaspects includingconsideration of other supportiveservice lineneeds.

• Contributes to the Research Executive Committee meetingsas needed to provide detailed information regarding potential clinical trials.

• Supervisesthestart-up studyprocessfor each clinical research teamtoensuretimely implementation of trial.

• Managetrial implementation barriers and collaborate with the Director HRPP to ensure resolution.

• Maintains a working knowledge of applicable Federal State and local laws and regulations Trinity Healths Organizational Integrity Program Standards of Conduct as well as other policies and procedures to ensure adherence in a manner that reflects honest ethical and professional behavior.

• Supervises the clinical teams to ensure adherence todepartmental guidelines and expectations that ensure compliance with research billing review practices.

• Supportsand mentors clinicalresearchcoordinator staff in the followingstudy relatedactivities:

• Feasibility assessments

• Submission to Research Executive Committee

• IRB submissions

• Maintenance ofIRB documentation

• Consent form development inclusive of vulnerable population legal andethical and religious directive considerations.

• Completion of study start upactivities

• Management ofenrolled study participants.

• Identification and verification of source documentation.

• Coordination of vendor and/or sponsor visits

• Facilitationof training requirementsfor the protocol specific research team.

• Completion of activities related to protocol amendments.

• Identification and management of reportableinformation

• Use of EMR and activities to support clinical research role.

• Lead and/orparticipateinweekly team meetings.

• Collaboratewith the Director HRPPtodevelopeducational sessions for staffto ensure awareness of new guidance or changes to regulationsand reiterationof content where additional learning is an identified need.

• In collaboration with the Director HRPPfacilitates legal submissionsandsupportsreview of research agreements.

• Maintains cooperative relationships with partnering surgical medical radiology and pathology departments as well as other disciplines and team members.

• Maintains a system for organizing planning and managing clinical researchstaff.

• Performsclinical researchquality assuranceactivities identifies performance gaps develops actions plans andmentor staffto ensure comprehension.

• Collaboratewith the EPIC TC team to ensure order sets are developed prior to study implementation and as applicable for clinical trials involving administration of an investigational product.

• Participates in monitoring visits andaudits ofclinical researchactivities to identify gaps in staff education and training or relevant departmental workflows and SOPs.

• Ensurestaff haveprovided timelyresponsetoauditfindings andotherqueries.

• Provides support to clinical teamsand collaborates with Director HRPPto ensure complete resolutionof audit and/or monitoring findings.

• Ability to work independently balances multiple projects and meets deadlines.

• Strong sense of teamwork and eager to assist with unique projects and interdepartmental needs when appropriate.

• Demonstrate analytical thinking problem solving and interpersonal skills.

• Experience usingMS Word and Excel MS Teams and Outlook and EPIC