JOB SUMMARY
The Senior CRC will work closely with Principal Investigators and clinical research teams to coordinate the daily operations of clinical research studies and oversee clinical research staff performing clinical functions at the designated Innovo Research partner site The Senior CRC will be responsible for making sure that all clinical research activities are efficiently executed, and conducted in a professional manner that is compliant with all human research subject regulations. Experience in cardiology is preferred.
RESPONSIBILITIES
-
Assist with mentoring and training clinical research staff.
-
Perform clinical functions i.e. phlebotomy, monitoring vital signs on study participants, etc., when warranted; educate family and contribute to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria.
-
Liaises with agencies, pharmaceutical companies, laboratories, vendors, equipment, and supply companies as needed; oversees availability of supplies and/or equipment for studies.
-
Manage multiple concurrent trials - screening, recruiting, and enrollment, perform patient/research participant scheduling, coordinate protocol-related research procedures, study visits, and follow—up, collect patient/ research participant history, collect and maintain source documentation, perform data entry and query resolution, prepare IRB submissions, update required modifications, continuing reviews, and reportable events.
-
Develop strong working relationships and maintain effective communication with study team members.
-
Completes all protocol-related training and adheres to IRB approved protocol(s)
-
Support the collection and review of required essential study documents and reports.
- Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-clinical supply materials, imaging, and laboratory handling manuals, etc.).
-
Assist in the informed consent process of research subjects.
-
Support and advocate for the safety of research subjects.
-
Facilitate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities.
-
Collect, process, and ship laboratory specimens.
-
Comply with Innovo, Clinic, and Sponsor policies, standard operating procedures (SOPs), applicable regulatory requirements and guidelines.
-
Performs all additional duties as assigned.
Qualifications
-
At least 3-5 years of experience coordinating clinical trials, including the activities listed above.
- Cardiology experience is preferred.
- BS/BA in Life Science or related discipline.
- Certified Clinical Research Coordinator (CCRC) certification preferred.
-
Previous GCP training and certification required and working knowledge of current ICH GCP guidelines and applicable regulations. Experience in a clinical setting.
-
Demonstrated ability in positive relationship building.
- Previous experience with training and mentoring other clinical research professionals is a plus.
-
Strong interpersonal skills with attention to detail a must. Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
-
Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems.
- Strong organization/prioritization skills for the management of multiple concurrent projects.
- An understanding of Regulatory and Central/Local ethic submission processes
- Ability to manage multiple competing priorities within various clinical trials.
- Excellent verbal and written communication skills required.
- Ability to work independently, prioritize, and work with a matrix team environment is essential.
- Ability to travel for Clinic activities, and attend investigator meetings or vendor visits/audits, as required.
BENEFITS (full-time)
- Competitive salary
-
Health Insurance
-
Dental Insurance
-
Disability Insurance
-
Life Insurance
-
Paid Time Off
-
Vision Insurance
WORKING CONDITIONS
This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and scanners. There is frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment. Varied activities include standing, walking, reaching, bending, and lifting. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 50 pounds. Requires corrected vision and hearing to normal range.
Due to the nature of this position, employees are expected to work in person. This is an exempt position under the federal and state wage and hour laws, which means you are not eligible for overtime pay beyond your salary. Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
