Tasks may include but are not limited to:

• Always represents our firm in a professional manner (verbal written and in appearance) when interacting with sponsors, subjects, outside vendors and fellow employees.
• Reviews study protocol and Investigator’s Brochure.
• Attends the investigator’s meeting, pre-study site visit, study initiation visit, and all other study-related visits by Monitors or Sponsor representatives.
• Establishes study regulatory document binder to maintain complete and accurate records of all Sponsor, Site, CRO, IRB/IEC correspondence and regulatory documents pertaining to the study.
• Performs quality checks on source documents specific to the study.
• Reviews approved regulatory documents from the IRB/IEC.
• Arranges for procedures performed by external vendors that are necessary to the conduct of the study.
• Attends in-house protocol meeting to review study-related procedures, staffing and visit flow.
• Schedules medical coverage for physicals, dosing, etc.
• Coordinates the trial from phone screening to randomization to study completion.
• Uses experience to schedule study procedures so they are efficient and timely for all involved while maintaining study integrity.
• Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose.
• Maintains and documents communication with Sponsor or Sponsor representative(s) throughout the clinical trial.
• Responsible for giving subject instructions at check-in and serves as the primary contact for subjects by being available to handle study-specific questions, concerns, or events.
• Ensures randomization procedures are completed per study requirement.
• Obtains and documents adverse event data on appropriate forms.
• Assures quality and completeness of source documents and Case Report Forms (CRFs) collected during the course of the study.
• Enters data into CRFs using 100% source documentation verification.
• Files interval (interim), annual reports, and/or final reports to the IRB/IEC, IND safety reports and other pertinent information throughout conduct of study.
• Assists with monitoring visits on site and available during visits for correction, questions, etc.
• After close-out visit has been conducted, prepares study documents for archiving, according to timelines.
• Reviews and signs final study reports.
• Responsible for completing all necessary training for the position, including DOPs and SOPs.
• Helps train new Coordinators, Assistant CRCs, and Research Associates by serving as a mentor.
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

• Excellent written and oral communication skills.
• Ability to understand complex written and oral instructions.
• Basic computer knowledge and applications required for generation of business correspondence and preparation of regulatory and other study documents.
• Strong interpersonal skills.
• Excellent attention to detail.
• Exceptional organizational skills.
• Ability to set and meet deadlines with high quality work.
• Knowledge of the clinical research process, including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting.

R.N. Strongly Preferred

Preferred: 2 to 5 years of clinical research experience.

The CRC works under the general supervision and guidance of the Study Principal Investigator.

The CRC is independently responsible for planning his/her work load and time required for the successful recruitment of volunteers who are eligible according to protocol inclusion and exclusion criteria. There will be times when an adjustment in work hours, to include weekends, is necessary. The responsibility will be inclusive of the time line required for successful enrolment of a clinical trial. Time lines will be dependent upon the length of the study, the length of time prior to study recruitment and length of time for study conclusion. The CRC is responsible for the workload assigned to him/her as the Principal Investigator deems necessary. Workload will be assessed by difficulty of protocol enrolment, length of clinical trial and quantity of clinical trials currently assigned to the CRC. The CRC is responsible for ongoing communications with the Study Conduct Manager, Project Manager and the Principal Investigator to ensure that timelines of assigned projects are met and that the integrity and quality of the clinical trial is maintained. Must be able to follow written and verbal communication. Must be punctual.

The CRC is responsible for eliciting and reviewing potential volunteers’ medical and medication histories to determine eligibility for participation in a clinical trial according to the protocol inclusion/exclusion criteria. Errors in judgment can negatively impact study enrollment and can potentially result in significant financial loss to CCR Job Description.

Accurately collecting and reporting information regarding the safety, well-being, and health/illness status of subjects during the course of their study participation is an important responsibility of this position. The CRC communicates the subject’s medical complaints, adverse events, concomitant medications, and abnormal laboratory findings to the study’s Investigator(s). Errors in collecting and relaying this information can compromise subject safety and even result in litigious activities at a significant expense to CCR.

The CRC is responsible for being knowledgeable of and compliant with the following guidelines: Good Clinical Practices, CCR’s SOPs, CCR’s DOPs, CCR’s “OSHA Compliance Manual” and CLIA regulations as they pertain to the laboratory certification category utilized at this facility. Non-compliance could compromise personal safety, subject safety and study quality and could result in damage to CCR’s reputation with individual Sponsors and in the research industry.

The CRC will be the primary contact for the study subjects, as well as site staff. He/she must be available for daily communication as per the demands for successful enrollment of a clinical research trial as well as the safety of the subjects. The CRC is responsible for communicating problems, questions and/or clarifications. These communications can include, but are not limited to, proper dispensing of test article, test article accountability, protocol clarifications, protocol deviations, scheduling of monitoring visits, adverse event reporting and enrollment updates. The CRC will communicate all problems, questions and/or clarifications to the Study Conduct Manager and/or Project Manager for their direct communication with the Sponsor. The CRC will work closely with the Recruitment Services Supervisor during the recruitment process. The CRC will work with the Coordinating Staff, Investigator(s), and the Study Conduct Manager as often as necessary for successful completion of the trial. The CRC will document and maintain records of all oral communications with the Sponsor’s representative in the Study Master File.

Possible mental demands include, but are not limited to: reading, math, intense concentration, verbal communication, written communication, client contact, attention to detail, multiple tasks, frequent interruptions, and fluctuation in work load. Job Description — CRC Version Date: February 2012

Possible physical demands include, but are not limited to: occasional lifting and carrying of objects weighing 5-15 lbs.; hearing; seeing; gross and fine motor use of upper extremities; kneeling; walking; standing; leaning over for extended periods; squatting; eye strain/fatigue; climbing; pushing; pulling; reaching; and exposure risk to potentially infectious blood and/or body fluids, fumes or chemicals. Lifting/carrying objects weighing 16-50 lbs.

Possible equipment includes, but is not limited to: computers, rolling carts, fax machine, photocopier, telephone, lab apparatus, mop/broom, needles, spirometry, centrifuges, allergy testing equipment, scales, microscope, calculators, vital signs equipment, and ECG machines.