Clinical Research Assistant

Greater Boston Urology • Plymouth, MA

34d • Onsite

About The Position

The Clinical Research Assistant (CRA) is responsible for helping to conduct and documenting clinical research and trials for the Research Division while adhering to Good Clinical Practice/ICH Guidelines and the Code of Federal Regulations.

Requirements

• Associates or Bachelor’s Degree from an accredited college or university.
• Good Clinical Practice (GCP) Certificate
• International Air Transport Association (IATA) Certificate
• CCRC certification through an accredited organization (ACRP/SoCRA) is required
• 2-3 years related Research experience Preferred.
• Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Computer Skills To perform this job successfully, an individual should have thorough knowledge in computer information systems.
• Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Nice To Haves

• 2-3 years related Research experience Preferred.

Responsibilities

• Administratively and clinically help coordinate with a team to work on a minimum of six clinical trials (level 1-3 clinical research protocol) .
• Help schedule, plan and participate in study monitoring visits and address any potential queries or deviations in accordance to the study protocol.
• Acts as a liaison between sponsor and the research department.
• In collaboration with the Clinical Manager advises treating physicians of clinical protocol opportunities and procedures.
• Recruitment of study subjects, including use of professional experience, discretion and judgment to include or exclude potential subjects based on trial criteria.
• Acts as a study resource for patients and family.
• Discusses study protocols with patients and verifies the informed consent process and documentation.
• Addresses any questions or concerns the research patient may have regarding the study.
• Provides patient with written communication of their participation.
• Ensures subjects understanding and willingness to continue participation as well as conduct study specific procedures and assessments (within his/her scope of practice) at each visit. This includes providing patients all treatment option information within their scope of practice such as pamphlets and protocol direction.
• Dispenses study medications in accordance to protocol requirements within his/her scope of practice.
• Performs Investigational Product accountability for accurate compliance.
• Collects, processes and ships blood/urine specimens at scheduled times.
• Contacts outside health care providers and communicates with subjects to obtain follow up information.
• Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials.
• Ensures filing and maintenance of all regulatory documents.
• Attends sponsor meetings for the purpose of education and understanding of protocols or protocol addendums.
• Maintains required continuing education hours required for certifications.
• Adherence and knowledge of OSHA including the location and use of Material Data Safety Sheets (MSDS).
• Maintains a high level of patient confidentiality.
• Performs all other duties as assigned.

Benefits

• Beyond competitive compensation, our well-rounded benefits package includes a range of comprehensive medical, dental and vision plans, HSA / FSA, 401(k) matching, an Employee Assistance Program (EAP) and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 101-250 employees