ZARS Pharma

Clinical Financial Manager and Research Associate 2 (E-4, Specialist 2)

Section: General

Department: Clinical

Reports To: CRA Director or Clinical Projects Director

Employment Status: Full Time

Job Summary:

The CFMRA is responsible for all of our contracts signed with investigators/investigative sites and making certain that they are appropriately administered and signed. The CFMRA will be responsible for our Clinical Trials Management System (CTMS) including the completion of development of the system. The CFMRA will also have project activities associated with monitoring functions of Phase 1 – 4 clinical research studies. These included investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs). The CFMRA is expected to discharge the following responsibilities in close collaboration with and under the supervision of the Clinical Projects Director or CRA Director.

Duties and Responsibilities:

• • Develops and executes our Clinical Study Agreements (CSA) for all ZARS clinical studies. Manages the integration of the agreements into the CTMS for automated accrual and financial activities.
• • Works with outside vendors and clinical staff to develop, integrate, facilitate, improve and maintain our CTMS. Resolve bugs. Chair the Monarch Review Committee.
• • Tracks the monthly financial accruals for all studies.
• • Using enrollment logs and requests from the site, manages the need for drug shipments to the investigative sites for all large studies such as the Thermoprofen phase 3 studies. Makes certain that sufficient supplies are available. Communicates this need with Project Management and Clinical Trials Management.
• • Takes leadership role in the establishment and maintenance of clinical financial and CTMS issues.
• • Assists in the development and review of study materials including but not limited to, sections of clinical study protocols, Case Report Forms (CRFs), data review guidelines, regulatory documents, edit checks, contracts
• • Assists with the study start-up activities related to monitoring.
• • Assists with site recruitment, selection, and initiation activities to identify and evaluate potential investigators.
• • Develops, collects, reviews, and files regulatory documents.
• • Assists with the development of initiation manuals, annotated CRFs, monitoring guidelines, monitoring conventions, tracking forms and other study-related documents.
• • Assists with the preparation and coordination of investigator meetings and attends meetings. Presents segments of the meeting.
• • Collects documents, researches websites, and conducts site qualification visits with study site staff to evaluate Investigator’s and site’s acceptability for study participation.
• • Conducts initiation visits with study staff to train, review regulatory requirements, collect outstanding documents, review patient screening/randomization procedures, review SAE reporting requirements, and review drug storage and accountability procedures.
• • Assists in the development of patient enrollment strategies with project teams and clinical trial sites.
• • Ensures the integrity of clinical data and adherence to applicable regulatory, protocol and company guidelines.
• • Ensures the proper storage, dispensation, and accountability of clinical trials materials.
• • Conducts interim monitoring visits to ensure the integrity of clinical data.
• • Performs site management activities.
• • Conducts peer review of CRFs and other documents involved in studies.
• • Conducts in-house monitoring activities.
• • Maintains patient tracking records for assigned sites.
• • Conducts and assists with administrative activities as a member of the project team.
• • Assists in the identification, qualification, and management of clinical research organizations.
• • Participates in the development of protocols, CRFs, site instruction materials, informed consents, and other monitoring tools for clinical trials.
• • Prepares confirmation and follow-up letters and monitoring reports.
• • Prepares SAE and Withdrawal-due-to-AE narratives.
• • Attends clinical training, project-specific, and other assigned/required meetings.
• • Maintains appropriate lines of communications with CRA Director, Project Director, Regulatory personnel, and others.
• • Maintains appropriate use of mail, telephone, and computer.
• • Negotiates and maintains study budgets. Prepares clinical trial agreements.
• • Compiles SAE information obtained from investigative site for the Medical Monitor.
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Knowledge, Skills, and Abilities:

• • Provides help and information freely without obstacles
• • Offers (shares) ideas and insights into other’s projects
• • Makes and keeps commitments
• • Offers solutions and ideas when identifying problems and does not intensify problems by escalating or giving incorrect information
• • Resolves conflict in an appropriate way. Deals directly with the other person(s) involved and does not triangulate problems or issues
• • Identifies problems and problem situations and offers ideas, opinions and solutions and then implements once the decision is made
• • Interacts with others with common courtesy
• • Seeks and uses constructive feedback
• • Provides constructive feedback
• • Initiates work related interactions with a broad spectrum of employees for input, ideas and solutions
• • Serves as a positive company representative
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Education and Experience:

• • Bachelor’s degree required (preference to scientific discipline) or RN with Associates degree or 3 year Nursing Diploma with at least 1 year of clinical nursing experience.
• • 2 years of clinical monitoring experience at a CRO or pharmaceutical or biotechnology company or at least 3 years of experience as an in-house CRA or at least 2 years experience as a study coordinator and 1 year clinical monitoring experience.
• • Knowledge and experience with CTMS (Clinical Trials Management System).
• • Knowledge and experience with investigative site contracts and grants.
• • Familiarity with medical terminology; ability to understand, interpret, and explain complex medical details.
• • Knowledge FDA/ICH Good Clinical Practice guidelines.
• • Excellent verbal and written communication skills.
• • Ability to work independently.
• • Excellent organizational, record retention, time management, decision making, and interpersonal skills.
• • Ability to travel at approximately 60 % level domestically and internationally.
• • Possession of credit cards for the purpose of paying expense while traveling and prepare expense reports for reimbursements.
• • Proficient in the use of laptop computer, the internet, and Microsoft Office software.

Send resumes to: resumes@zars.com