Clinical Research Associate II

Summary: Under the supervision of the Associate Director, CRA Services, conducts site monitoring for clinical research studies according to ProSciento Standard Operating Procedures (SOPs) and ICH/GCP/GLP guidelines. Prepares monitoring reports and assists with query resolution. Performs duties in accordance with the company’s values, policies, and procedures.

Essential Duties and Responsibilities include the following. Other duties may be assigned at the Company’s sole discretion.

• Responsible for all aspects of study site monitoring including site qualification visits, pre-study visits, site initiation visits, routine monitoring visits, and close-out visits of clinical sites.
• Ensures the protection of study subjects by verifying that informed consent procedures have been followed and protocol requirements are adhered to according to applicable regulatory requirements.
• Monitors, tracks, and follows up on all Adverse Events (AEs) and Serious Adverse Events (SAEs). Ensures all SAEs are reported to sponsor and regulatory authorities within required timelines.
• Ensures the accuracy and integrity of the data submitted on electronic or paper Case Report Forms (CRFs) or other data collection tools by comprehensive source document review. Monitors data for missing or discrepant data.
• Ensures all required monitoring tasks are conducted according to SOPs, established guidelines, work instructions (WIs), monitoring plans, and project plans.
• Conducts eCRF/CRF review, query generation, and resolution against established data review guidelines.
• Assists with feasibility collection and general collection of investigator regulatory documents.
• Creates spreadsheets or other tracking tools used to update and track study milestones and progress.
• Attends investigators’ or site initiation meetings, project team meetings, and teleconferences, as needed.
• Understands and applies knowledge regarding local, state, and country regulations and industry guidelines, e.g., HIPAA, CA Bill of Rights, International Conference on Harmonization (ICH), and Good Clinical Practices (GCP’s).
• Working knowledge of electronic systems e.g., e-CRF, electronic Trial File Master (e-TMF), and Clinical Trial Management System (CTMS).
• Responsible for attending all required training, study-specific training, and assisting in training of other co-workers.
• Performs other duties as assigned by ProSciento management.
• Solid knowledge of electronic systems e.g. e-CRF, electronic Trial File Master (e-TMF), and Clinical Trial Management System (CTMS).
• Assists with monitoring report review for other CRAs.
• Organizes, develops, and delivers presentations at investigator and study initiation meetings.
• Participates, as requested, in ProSciento’s Continuous Quality Improvement (CQI).
  
  
  

Travel Requirements:

• Able to travel via airplane, train, or motor vehicle to respective research sites or investigator meetings.
• Must be able to travel out of the local office or from home up to 75% of the time, including overnight stays at hotels or other designated facilities.
• Must be able to drive and have a valid driver’s license.
  
  
  

Financial Requirements:

If applicable, a company credit card may be issued and must only be used for reasonable expenses incurred on the company’s behalf (e.g. to arrange travel, book hotel, car rental, taxi, and purchase food).

Competencies:

• Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
• Functional/Technical Skills: Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
• Peer Relationships: Can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.
• Presentation Skills: Is effective in a variety of formal presentation settings; one-on-one, small and larger groups, with peers, direct reports, and bosses; is effective both inside and outside the organization, on both cool data and hot and controversial topics; commands attention and can manage group process during the presentation; can change tactics midstream when something isn’t working.
• Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.
  
  
  

Qualifications:

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 individuals with disabilities to perform the essential functions.

Education/Experience:

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing, respiratory, certification, medical or laboratory technology), or equivalent combination of education and experience.
• In lieu of the above requirement, candidates with two or more years of relevant clinical research experience in clinical research, pharmaceutical, or CRO industries will be considered.
• Basic understanding of ICH/GCP guidelines, including a basic understanding of regulatory requirements and the clinical trial process.
• Knowledge of medical terminology, clinical research acronyms, and medical/scientific abbreviations.
• All experience defined above, but with a minimum of four or more years of relevant clinical research experience in the biopharmaceutical, or a CRO.
  
  
  

Skills, Knowledge, and Abilities:

Ability to independently and accurately perform clinical data review of source documents and case report forms. Ability to follow study specific guidelines, plans, and manuals, and participate in all aspects of training in addition to performing verification and resolution of data queries/discrepancies within defined timelines. Ability to understand and follow oral and written instructions precisely. Solid communications skills, with co-workers, investigative site, and sponsor/vendor representatives required. Ability to work in a fast-paced environment and adapt easily to changing priorities.

Language Ability:

Ability to speak, read, understand and write English. Ability to read and interpret scientific journals, study protocols, investigator brochures, study manuals and ancillary documents such as SOPs and equipment and laboratory procedure manuals. Possess the ability to write routine reports and correspondence, and to speak effectively before groups of customers or at sites.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Possess the ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Reasoning Ability:

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Possess the ability to deal with problems involving several concrete variables in standardized situations.

Computer Skills:

To perform this job successfully, an individual should have knowledge and proficiency in the current Microsoft Office Suite.