Overview

Job Description Summary:

Oversees administrative operations for multi-center clinical trials, projects, and portfolios within the Clinical Research Office (CRO). Accomplishes program goals through excellent interpersonal communication along multi-center study start-ups, consortium development, and department or center portfolio development.

Job Description

Essential Functions:

• Coordinates and manages clinical research studies and ensures compliance with protocols and regulations.
• Develops and maintains study budgets and tracks expenses. Oversees IRB process, ensures sites are submitting complete, accurate and timely IRB submissions, and maintains associated regulatory documents.
• Recruits and screens potential study participants and obtains informed consent.
• Collects, analyzes, and maintains accurate study data and records. Identifies areas of risk and implements new or revised processes, collaborates to create new processes, and improves efficiencies to ensure overall program success.
• Collaborates and communicates with study sponsors, investigators, and staff. Assists with orientation and training and implements training materials.
• Prepares and submits study progress reports to regulatory agencies and study sponsors.

Education Requirement

• Associate degree, required.
• Bachelor’s Degree, preferred.

Licensure Requirement

(not specified)

Certifications

CCRC or CCRP certification within 12 months of hire and maintained throughout employment, required.

Skills

• Demonstrated leadership skills
• Strong organizational skills.
• Exceptional interpersonal, written, and verbal communication. Takes opportunities to provide leadership within the team through communicating effectively, developing others, valuing, and building on diversity and differences within the team, building and maintaining relationships, and assisting in ensuring effective and compliant teams and work groups.
• Ability to filter information, discern importance and initiate plan for project completion.
• Self-directed, results driven with the ability to manage workload.
• Ability to work independently and as part of a team.
• Working knowledge of data management software.

Experience

Three years’ experience in clinical research or healthcare related field, required.

Physical Requirements

OCCASIONALLY: Bend/twist, Squat/kneel

FREQUENTLY: Lifting / Carrying: 0-10 lbs, Lifting / Carrying: 11-20 lbs, Pushing / Pulling: 0-25 lbs, Pushing / Pulling: 26-40 lbs, Standing, Walking

CONTINUOUSLY: Audible speech, Color vision, Computer skills, Decision Making, Depth perception, Flexing/extending of neck, Hand use: grasping, gripping, turning, Hearing acuity, Interpreting Data, Peripheral vision, Problem solving, Reaching above shoulder, Repetitive hand/arm use, Seeing – Far/near, Sitting

Additional Physical Requirements Performed But Not Listed Above

(not specified)

"The above list of duties is intended to describe the general nature and level of work performed by individuals assigned to this classification. It is not to be construed as an exhaustive list of duties performed by the individuals so classified, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under their supervision. EOE M/F/Disability/Vet"