Clinical Research Contracting Specialist

Tucson Medical Center; Tucson (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Tucson Medical Center seeks a Clinical Research Contracting Specialist to lead the development, review and negotiation of CTAs, CDAs, master agreements, and related contracts. You will collaborate with investigators, sponsors, CROs, and legal to facilitate trial startup and ongoing study support.

You will oversee contract lifecycle, ensure compliance with fiscal/organizational standards, and provide guidance on contracting processes while maintaining confidentiality and data protection across

Qualifications

• Bachelor’s degree in business or related field.
• 3 years of relevant contract administration, negotiation or healthcare/clinical research support.
• Experience reviewing and negotiating clinical research agreements preferred.
• Knowledge of clinical trial contracting processes and lifecycle management.
• Ability to interpret contract provisions and regulatory requirements.

Responsibilities

• Negotiate and manage Clinical Trial Agreements, CDAs, Data Use Agreements and related contracts.
• Collaborate with investigators, sponsors, CROs, legal, and compliance to start and support studies.
• Identify and negotiate terms on indemnification, IP, publication rights, confidentiality and insurance.
• Oversee contract lifecycle, vendor performance and compliance with fiscal/organizational standards.
• Provide guidance on contract processes to investigators and staff.
• Maintain knowledge of federal regulations and sponsor requirements relevant to contracts.

Skills

Contract negotiation

Clinical research contracts

Communication skills

Regulatory compliance

Vendor relations

Education

Bachelor’s degree in business or related field

Tools

Microsoft Office

Adobe Acrobat Pro

symplr contract management systems

Job description

Clinical Research Contracting Specialist

Job Category Professional

Schedule Full time

Shift 1 - Day Shift

Summary:

Assistsinmaintainingaconsistent,organization-widecontractingpolicy.Specializesindevelopment,reviewand negotiation of complex and unique contracts, such as Clinical Trial Agreements (CTAs), Confidentiality Disclosures (CDAs), Master Clinical Trial Agreements, Investigator Initiated Trial Agreements, Data Use Agreements, and other research-related contracts.Works collaboratively with investigators, clinical research staff, legal counsel, compliance, sponsors, and CROs to facilitate clinical trial startup and ongoing study support.

Responsibleforreportingconditionswhichposeaninordinateriskoflossandothersimilaractswhicharesubject to detection through the application of normal audit procedures. Oversees the contract lifecycle ensuring vendor performance, customer satisfaction, market-competitive terms, and compliance with fiscal and organizational standards in collaboration with the responsible manager, director or executives.

Essential Functions:

Demonstratesabilitytoensureuseofpropercontractualdocument,includingthecreationoforiginalagreements and original contract clauses when appropriate to address unique situational needs.Demonstratesnegotiationskills,andtheabilitytonotonlyaddressdiversepoints,buttheabilitytodelayresponses when appropriate.

Reviews, negotiates, and manages lifecycle of Clinical Trial Agreements, Confidential Disclosure Agreements, Data Use Agreements, Letters of Indemnification, budget-related contract provisions, and other research-related agreements.

Collaborates with sponsors, contract research organizations (CROs), investigators, research administration, compliance, legal counsel, and finance personnel to ensure timely contract execution.

Identifies and negotiates contractual terms related to indemnification, intellectual property, subject injury, publication rights, confidentiality, insurance, payment terms, and regulatory compliance.

Provides guidance regarding research contract processes and requirements to investigators and clinical research staff.

Maintains working knowledge of federal regulations, sponsor requirements, and contractual standards applicable to clinical research activities.

Demonstratesabilitytocoordinatethedevelopmentofanewprojectornewcontractsubtype,seeitthroughto completion and with Manager oversight, establish parameters for department processing.

Independentlydemonstratestheabilitytodevelopcontractualstrategies,positions,andcounterargumentsinboth impromptu and prepared situations, and assists Manager and other department staff when needed.

Actsassecondaryadministratorforcontractmanagementsystem,performingoversightofthesystemand maintaining the quality of the information.

Workscollaborativelyandsupportseffortsofotherdepartmentmembers,providingguidancewhennecessaryto other Contracting Specialists.

Supportsdepartmentprocessimprovementinitiativesthroughteamparticipation,dataanalysis,processchange implementations and other activities.

Servesasaresourcepersonandfacilitatoranddevelopseffectiveworkingrelationshipswithbothinternal customers and outside suppliers; develops national, regional, and local alliances.

Providesdirectiontooperationaldepartmentsregardingthecontractingprocessanddevelopmentofscopeand/or business plans when needed.

Adherestoorganizationalanddepartment-specificsafetystandardsandguidelinesandestablishedstandardsof behavior.

AdherestoTMCHvaluesofintegrity,diversity,accountability,compassion,andteamwork.

Maintainsconfidentialityandalwaysprotectssensitivedata,includingpatientinformation,proprietaryinformation, and personnel information.

Performsrelateddutiesas assigned.

Minimum Qualifications

EDUCATION

Bachelor’sdegreeinbusinessorrelatedfield.

EXPERIENCE

Three (3) years of relevant contract administration, contract negotiation, legal support, healthcare administration, clinical research administration, or related experience required. Experience reviewing and negotiating clinical research agreements preferred.

LICENSURE OR CERTIFICATION

Nonerequired.

KNOWLEDGE, SKILLS, AND ABILITIES

• Demonstratedhighabilitytoeffectivelycommunicatethroughwrittenandverbalcommunication;saidability must include formal, technical, persuasive, and instructional areas

• Musthavedemonstratedabilityto:(a)successfullymanagehighvolumeworkload;(b)prioritizecompeting needs appropriately; (c) successfully work under pressure and with short deadlines.

• Knowledge of clinical trial contracting processes and lifecycle management.

• Ability to interpret and negotiate contract provisions commonly found in Clinical Trial Agreements and related research contracts.

• Familiarity with the regulatory environment governing clinical research activities.

• Understanding of contract terms involving intellectual property, publication rights, confidentiality, subject injury, indemnification, and insurance requirements.

• Ability to build collaborative relationships with investigators, sponsors, CROs, and research administration personnel.

• Musthavehighlevelofknowledgeandabilityincomputer-relatedapplications,especiallyMicrosoftOffice, Adobe Acrobat Pro and symplr contract management systems.

• Skilledincreatingandmaintaininggoodworkingrelationshipsoftrustwithvendorsandinternal personnel.

• Abilitytouseindependentjudgmentandcreativityinsolvingproblemswithavarietyofconcreteandfluid variables.

• Mustbesufficientlyhighlyorganizedanddetail-orientedtobeabletoprovideverbalstatusupdates quickly.

• Skillinnegotiatingwithanunderstandingofcontractingimplicationsforamulti-facility organization.

• Abilitytoread,analyze,andinterpretcontractlanguage,financialimpacts,andgovernmental regulations.

• Abilitytowritereports,businesscorrespondence,andprocedure manuals.