Clinical Research Contracting Specialist
Description
Summary:
Assists in maintaining a consistent, organization-wide contracting policy. Specializes in development, review and 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.
Responsible for reporting conditions which pose an inordinate risk of loss and other similar acts which are subject 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:
Demonstrates ability to ensure use of proper contractual document, including the creation of original agreements and original contract clauses when appropriate to address unique situational needs.Demonstrates negotiation skills, and the ability to not only address diverse points, but the ability to delay responses 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.
Demonstrates ability to coordinate the development of a new project or new contract subtype, see it through to completion and with Manager oversight, establish parameters for department processing.
Independently demonstrates the ability to develop contractual strategies, positions, and counterarguments in both impromptu and prepared situations, and assists Manager and other department staff when needed.
Acts as secondary administrator for contract management system, performing oversight of the system and maintaining the quality of the information.
Works collaboratively and supports efforts of other department members, providing guidance when necessary to other Contracting Specialists.
Supports department process improvement initiatives through team participation, data analysis, process change implementations and other activities.
Serves as a resource person and facilitator and develops effective working relationships with both internal customers and outside suppliers; develops national, regional, and local alliances.
Provides direction to operational departments regarding the contracting process and development of scope and/or business plans when needed.
Adheres to organizational and department-specific safety standards and guidelines and established standards of behavior.
Adheres to TMCH values of integrity, diversity, accountability, compassion, and teamwork.
Maintains confidentiality and always protects sensitive data, including patient information, proprietary information, and personnel information.
Performs related duties as assigned.
Minimum Qualifications
EDUCATION: Bachelor’s degree in business or related field.
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: None required.
KNOWLEDGE, SKILLS, AND ABILITIES:
Demonstrated high ability to effectively communicate through written and verbal communication; said ability must include formal, technical, persuasive, and instructional areas
Must have demonstrated ability to: (a) successfully manage high volume workload; (b) prioritize competing 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.
Must have high level of knowledge and ability in computer-related applications, especially Microsoft Office, Adobe Acrobat Pro and symplr contract management systems.
Skilled in creating and maintaining good working relationships of trust with vendors and internal personnel.
Ability to use independent judgment and creativity in solving problems with a variety of concrete and fluid variables.
Must be sufficiently highly organized and detail-oriented to be able to provide verbal status updates quickly.
Skill in negotiating with an understanding of contracting implications for a multi-facility organization.
Ability to read, analyze, and interpret contract language, financial impacts, and governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.