Manager, Oncology Research Contracts & Agreements

Clinical Research Manager

This job manages all functions and activities within assigned unit, including evaluating the feasibility of clinical trials, implementing clinical trials, assisting in designing and developing protocols, and collecting and processing human specimens. Acts as a liaison to both internal and external investigators and industry representatives. Complies with all institutional, federal and international regulations ensuring proper subject protection. Trains and develops staff and facilitates the research conducted by investigators.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.

This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.

Education

Required - Bachelor's degree in life/health sciences. In lieu of a degree the applicant must have 6 years of experience in clinical research and 5 years of relevant leadership experience.

Preferred - Master's degree in life/health sciences, business or related field.

Work Experience

Required: 6 years of experience in clinical research + 3 years of relevant leadership experience with a Bachelor's degree.

OR

6 years of experience in clinical research + 5 years of relevant leadership experience with no Bachelor's degree.

Certifications

Required - Certification from a relevant accredited research institution/professional organization such as the Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SOCRA), or International Society for Biological and Environmental Repositories (ISBER) within 1 year of hire.

Knowledge Skills and Abilities (KSAs)

• Proficiency in using computers, software, and web-based applications, including Epic and electronic data capture.

• Basic knowledge of Microsoft Word and Excel.

• Effective verbal and written communication skills and ability to present information clearly and professionally, including in a presentation format.

• Excellent interpersonal, organizational and time management skills and ability to balance meetings, training, relationship-building, oversight, documentation, and outreach.

• Strong decision-making ability and conflict resolution skills.

• Ability to be self-directed, work independently, set priorities and maintain complete confidentiality.

• Strong leadership skills and ability to effectively lead a research team and exercise independent judgment.

• Ability to evaluate and implement clinical trials.

Job Duties

• Oversees regulatory and budget/contract processes for new research proposals including project feasibility and identifying protocol-related expenses.

• Manages protocol implementation to ensure efficient execution of trials within established budgets and timelines and meet enrollment targets.

• Sources equipment and materials needed to perform protocol-related activities.

• Assists in campaigns to increase recruitment, visibility, and awareness of relevant research in the industry and community.

• Assists in the recruitment/selection of new investigators, contract research organizations and outside vendors.

• Plans, coordinates, and manages the daily operations of research staff.

• Interviews, hires and conducts performance reviews of employees, with a focus of hiring and maintaining an engaged workforce.

• Forecasts and anticipates staffing needs to accommodate changes in protocol requirements and meet strategic growth plan of department.

• Develops and revises organizational structures to meet functional needs ensuring communication, reporting and incentives align people and processes.

• Performs other related duties as required.

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards.

This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.

The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Physical and Environmental Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Sedentary Work - Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Normal routine involves no exposure to blood, body fluid or tissue, but exposure or potential for exposure may occur.

The incumbent works with patients who have known or suspected communicable diseases and may enter isolation rooms. The incumbent has an occupational risk for exposure to all communicable diseases.

Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role.