Manager, Clinical Protocol Admin

Summary

The primary purpose of this position is to direct administrative and clinical support for research activities in the Department of Gastrointestinal Medical Oncology.

Core Values

Caring Behaviors

• Courtesy: Is respectful and courteous to each other at all times
• Friendliness/Teamwork: Promotes and rewards teamwork and inclusiveness; Is sensitive to the concerns of our patients and our co-workers

Integrity Behaviors

• Reliability: Communicates frequently, honestly and openly
• Accountability: Holds self and others accountable for practicing our values
• Safety: Notices a safety concern and brings it to someone's attention; Models safe behaviors (wears badge, washes hands, keeps work area clean and orderly); Mitigates risk to the institution through sound business practices

Discovery Behaviors

• Responsiveness: By his/her actions, creates an environment of trust; Encourages learning, creativity and new ideas
• Personal Leadership/Self-Initiative: Helps others to identify and solve problems; Seeks personal growth and enables others to do so

Key Functions

1. Clinical Protocol Administration / Regulatory Compliance

• Manages large-scale and multiple site research activities including implementation of clinical trials, regulatory compliance, quality assurance, electronic submission of patient data, and resolution of monitor findings.
• Oversee and coordinate IRB submission of new and amended protocols for the department, including creation or revision of relevant documents. Work with individual Principal Investigators, administrative assistants and research staff members to assure that revisions or amendments are submitted and ensures that desired outcomes are reached on a timely basis. Collect and develop criteria information for protocol submission.
• Reviews protocols, amendments and ancillary documents for discrepancies and/or lack of clarity. Works with PI and/or Sponsor to resolve.
• Establish a system for the tracking of all research related paperwork including protocol submissions, approvals, contracts and amendments and ensures adherence to deadlines.
• Develops and manages the department implementation of systems, policies, and procedures affecting the submission, review, approval, activation, regulation, tracking, and reporting of protocols, according to institutional and external requirements.
• Independently prepares protocol submissions that comply with regulatory and institutional requirements. Works with the study sponsors and/or Clinical Research Organizations (CROs) to facilitate the approval of regulatory documents that conform to both institutional and sponsor requirements.
• Coordinate and oversee activities associated with study start up and site initiation visits.
• Ensure proper authorization has been received before new protocols are opened, assist with continuing reviews and protocol terminations as needed.
• Audits or coordinates audits of systems and practices to ensure quality and regulatory compliance.
• Prepares applications and annual reports for new drug applications or devices, including correspondence with FDA.
• Assist with the department concept and protocol review committee process.
• Review new concepts and protocols in development and provide the principal investigator with recommendations regarding patient safety, protocol inconsistencies and requirements.
• Ensures protocol annual reports are submitted as per regulations.
• Liaison to principal investigators providing guidance on an issues regarding clinical protocols. Also communicates with regulatory agencies and sponsors on department's behalf.
• Acts as a liaison with private industry pharmaceutical companies to aid in the completion of ICD language appropriate for clinical trials.
• Ensures HIPPA compliance on all submitted protocols.
• Manage the collection and submission of other regulatory documents as needed to ensure the IRB, Sponsor, Cooperative Groups, and other regulatory agencies receive all required paperwork.
• Communicate with department financial team of upcoming therapeutic clinical trial

activations/amendments/closures/terminations.

• Provide oversight of central departmental regulatory files and submission of regulatory documents to sponsors as needed for each assigned study.
• Act as the departmental liaison with the various central institutional offices (Office of Protocol Research, Investigational New Drug Office, Consent Editors, Institutional Review Board, etc.) and with external contacts (Pharmaceutical Companies Representatives, Cooperative Group Representatives, and/or other collaborative academic institutions, etc.).
• Participate on project teams to provide regulatory leadership and input. Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the need and importance of regulatory requirements.

1. Planning and Development

• Collaborate with GIMO leadership in establishing departmental goals, strategies and procedures in support of business objectives. Perform regulatory compliance diligence to support clinical trial goals.
• Develops and administers a strategic plan to manage departmental protocol activity and regulatory management.
• Identifies and evaluates potential projects. Partners with department leadership, PIs, and regulatory staff to establish priorities and project schedules.
• Facilitate cohesiveness to improve regulatory compliance consistency and integration of department goals.
• Assists in assessing feasibility for protocols and prioritization for submission.
• Assists in the development of in-service educational events for departmental team members.
• Participates in the development of departmental policies and procedures related to protocol research.

1. Personnel Management

• Establishes performance and productivity standards for staff. Ensures the appropriate and maximum utilization of team personnel, providing timely and ongoing performance feedback in order to maintain required standards and achieve stated goals.
• Coaches and counsels employees and, when required, implements the disciplinary process within institutional guidelines.
• Ensures staff attendance at mandatory inservices and compliance with federal and state and accreditation regulations.
• Recruits, hires, orients and trains the regulatory support staff
• Completes annual performance evaluations and works with team members to establish annual performance and development goals.
• Supervises regulatory support staff, currently a team of 9 employees.
• Attend appropriate departmental meetings and institutional continuing education programs. Share new information with clinical research staff.
• Orients new faculty/support personnel on department's clinical trials research infrastructure and procedures.
• Ensures compliance with Good Clinical Practice standards.
• Maintains knowledge of clinical trials process.

1. Other duties as assigned.

• Serves as a content expert on various divisional and institutional committees and workgroups.

The above functions require the following abilities and skills:

• Must have good analytical and conceptual skills paired with detail orientation, exceptional interpersonal skills, and a demonstrated ability to creatively and innovatively approach problem-solving.
• Displays the ability to work closely with others, communicates clearly and develops efficient systems to promote a high level of productivity. Is able to function professionally and effectively and to influence others to do likewise under occasionally highly stressful conditions.

• Assimilates pertinent information in order to compose written correspondence (must have a strong command of the English language, including spelling, writing, and verbalizing) and be able to communicate well verbally and in writing.

• Understands and follows verbal and written directions, reads and understands printed and written data, organizes and disseminates information in a clearly understood manner, and is clearly understood by verbal communication in face-to-face encounters and by telephone.
• Must have the ability to travel to and from different destinations. Must also be able to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, lifting, etc.

The performance for all expected outcomes is measured by observation by supervisor, reports from faculty and staff, the accuracy and timeliness of work produced, and demonstration of the ability to effectively work under stress and anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform any necessary tasks, and to comprehend the goal of the department and take the initiative in making decisions and taking actions to further this goal. The ability to deal effectively with a variety of individuals and situations is essential.

Core Competencies

• IC - Coach and Develop:
  • Assess strengths and development needs of employees;
  • Provide challenging development opportunities
  • Provide relevant and timely feedback; and
  • Mentors others.
• IC - Provide Direction:
  • Provide clear direction and priorities toward a common vision;
  • Clarify roles and responsibilities for employees; and
  • Promote empowerment.
• IC - Build Relationships:
  • Initiate, develop, and manage relationships and networks; and
  • Show sincere interest in others and their concerns.

Education

Required: Bachelor's in Science, Healthcare, Nursing or related field.

Preferred: Master's in Science, Healthcare, Nursing or related field.

Experience

Required: Six years of extensive research administrative experience in a biotechnology or academic setting to include two years' experience with research protocols, grants and contracts and two years supervisory/management experience. May substitute additional experience for required education (or vice versa) on a one to one year basis

Working Conditions

This position requires:

Working in Office Environment

______ No

__X__ Yes

Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic)

__X__ No

______ Yes

Exposure to human/animal blood, body fluids, or tissues

__X__ No

______ Yes

Exposure to harmful chemicals

__X__ No

______ Yes

Exposure to radiation

__X__ No

______ Yes

Exposure to animals

__X__ No

______ Yes

Physical Demands

Indicate the time required to do each of the following physical demands:

Time Spent

Never

0%

Occasionally

1-33%

Frequently

34-66%

Continuously

67-100%

Standing

Walking

Sitting

Reaching

Lifting/Carrying

Up to 10 lbs

10lbs to 50 lbs

More than 50 lbs

Pushing/Pulling

Up to 10 lbs

10lbs to 50 lbs

More than 50 lbs

xx

Use computer/keyboard

Bachelor's degree in Science, Healthcare, Nursing or related field. Six years of extensive research administrative experience in a biotechnology or academic setting to include two years experience with research protocols, grants and contracts and two years supervisory/management experience. May substitute additional experience for required education (or vice versa) on a one to one year basis. Successful completion of the LEADing Self Accelerate program may substitute for one year of required supervisory or management experience. Must pass pre-employment skills test as required and administered by Human Resources. It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html