ONE YEAR CONTRACT ASSIGNMENT

Primary purpose and function of this position

· To be responsible for overall clinical site management including monitoring to fully ensure
patient safety, verification of source versus Case Report Forms to ensure accurate and
complete data and compliance with protocol (s) and Federal regulations, ICH, GcPs. Helps
to ensure that the quality of work and data are suitable to support New Drug Applications
(NDAs).

Major duties and responsibilities that are critical and necessary, and that must be done to

achieve this position’s overall objective

% of Time

50%
- Conducts all applicable site visits including: Pre-Study, Initiation, Interim, and Close-out
- Assists with project initiation and project implementation
- Assists with writing and development of informed consents, protocols, and amendments
- Assists with planning and tracking of projects and produces key progress reports
- Reviews and tracks regulatory documents at study start-up and during the trial
- Develops generic/study-specific source documentation
- Develops monitoring tools for CRAs
- Assists with review and design of Case Report Forms
- Completes routine site follow-up reports and appropriate confirmation and follow-up letters

15%

- Assists in the tracking of activities relevant to the progress of clinical studies
- Creates reports with trial status information for dissemination to study team members
- Authorizes drug shipments & tracks study supplies
- Assists with contract development, tracking, and negotiation for sites

15%

Partners with Clinical Trials Manager or Clinical Trial Leads to develop timelines,

milestones, budgets, contracts, processes, consistency in protocols, CRFs, for clinical

studies/programs

10%

- Serves as back-up and/or primary contact and resource expert for vendors, CRAs,

investigative sites, local and global team members
- Supervises CRAs
- Provides project -related training
- Monitors team members’ performance for performance evaluations
- Assists managers with interviewing candidates for CRA, and other project-related

positions

10%

Assists in the selection of CRO, SMOs and managing the delegated activities of CROs/vendors.

Oversees communication among CROs, contract CRAs and global team members on a project level

Travel: Up to 90%, primarily domestic

Core Competencies (five or six) that an incumbent needs to be successful
in this position and that distinguish this position from others similar to it:

Technical
- Demonstrates the ability to acquire a working knowledge of applicable medical indications
- Demonstrates an understanding of trial and protocol objectives
- Working knowledge of FDA regulations/guidelines, ICH guidelines, Good Clinical Practices
(GCPs)
- Familiarity with drug development processes
- Demonstrates a good working knowledge of medical terminology and medications
- Proficient in Microsoft Office and e-mail
- Thorough understanding of clinical trial and protocol objectives
- Thorough knowledge of FDA regulations/guidelines, ICH guidelines, Good Clinical Practices
(GCPs)
- Demonstrates a thorough understanding of assigned protocols and CRF requirements

Development of Self and Others
- Develops skills and comprehensive understanding of management and oversight of all tasks
performed in the day-to-day operation of a clinical trial

Interpersonal
- Able to work with people at all levels, internal and external to the company

Communication
- Communicates well with others as appropriate, within and across functions
- Produces timely and accurate reports
- Communicates with multiple entities, including medical personnel, to accomplish objectives
- Presents clear, concise, well organized written and oral communications
- Pro-actively and promptly updates/informs others of relevant concerns verbally and in
concise written form
- Responds promptly and follow up to ensure action is taken on recommendations and
opportunities
- Produces clear, concise reports with minimum guidance

Leadership
- Delegates effectively
- Leads, mentors, and assist
- Recognizes contributions of associates and peers
- Leads projects and other work
- Explores and relentlessly purses opportunities to improve projects
- Identifies and resolves issues
- Understands goals and initiatives of upper management and integrates into work efforts
- Establishes, fosters and maintains productive relationships with other in site or vendor
organization to work for a common cause.

Planning and Organization
- Approaches work with a strategic focus
- Knows and uses disciplined planning and organizational skills and practices
- Detail-oriented
- Self-motivated
- Produces accurate work with attention to detail
- Sets appropriate priorities
- Plans, organizes, manages and monitors activities according to priorities

Problem Solving
- Uses solution-oriented approach and proficient problem-solving skills. Gains cooperation
and alignment.
- Reviews and assures accurate and complete data.
- Identifies and solves problems proactively, not reactively
- Gains cooperation and alignment-resolves conflict

Teamwork
- Provides back-up and support to other team members
- Shares ideas, information, and suggestions among team members

Qualifications necessary to perform successfully in this position
Education required: Bachelor of Science Degree in Life Sciences or equivalent combination

of education and related work experience
Years of experience required: Combination of 3-4 years of monitoring and 1 to 2 years
of study management experience
Years of experience preferred: 4-5 years monitoring