Senior Clinical Research Coordinator

INNOVO RESEARCH INC•Austin, TX

3d•$59,481 - $80,000•Onsite

About The Position

The Senior Clinical Research Coordinator (CRC) works 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 a designated Innovo Research partner site. The role ensures research activities are efficiently executed, conducted professionally, and compliant with human research subject regulations. This position is based in a professional clinical environment and is performed in person. Employees are expected to work 40 hours per week. Occasional evening and weekend work may be required as duties demand. The position is exempt and is not eligible for overtime pay.

Requirements

At least 3–5 years of experience coordinating clinical trials, including the activities described in the posting.
BS/BA in Life Science or a related discipline.
Previous Good Clinical Practice (GCP) training and certification.
Working knowledge of current ICH GCP guidelines and applicable regulations.
Experience in a clinical setting.
Strong interpersonal skills and attention to detail.
Ability to interact with all levels of staff to coordinate and execute study activities.
Proficiency with word processing, spreadsheet, database, and presentation software, including MS Office applications such as Outlook, Word, Excel, PowerPoint, and SharePoint, and with clinical trial master filing systems.
Strong organizational and prioritization skills to manage multiple concurrent projects and competing priorities across clinical trials.
Understanding of regulatory and central/local ethics submission processes.
Excellent verbal and written communication skills.
Ability to work independently, prioritize work, and operate in a matrix team environment.
Ability to travel for clinic activities and attend investigator meetings or vendor visits/audits as required.
Ability to meet the physical requirements of the role, including standing and walking for extended periods, handling and lifting patients, and occasionally lifting and carrying items weighing up to 50 pounds.
Corrected vision and hearing within the normal range.
Authorization to work for any employer in the United States; the employer is unable to sponsor or take over sponsorship of an employment visa.

Nice To Haves

Certified Clinical Research Coordinator (CCRC) certification.
Previous experience training and mentoring other clinical research professionals.

Responsibilities

Assist with mentoring and training clinical research staff.
Perform clinical functions such as phlebotomy and monitoring study participants' vital signs when warranted; educate families and contribute to the care and evaluation of subjects, including determining preliminary inclusion and exclusion criteria.
Liaise with agencies, pharmaceutical companies, laboratories, vendors, and equipment and supply companies; oversee the availability of study supplies and equipment.
Manage multiple concurrent trials, including screening, recruiting, and enrolling participants; scheduling participants; coordinating protocol-related procedures, study visits, and follow-up; collecting participant history; maintaining source documentation; entering data and resolving queries; and preparing IRB submissions, modifications, continuing reviews, and reportable events.
Develop strong working relationships and maintain effective communication with study team members.
Complete protocol-related training and adhere to IRB-approved protocols.
Support the collection and review of required essential study documents and reports.
Order supportive study supplies, such as contracts, IXRS, lab kits, non-clinical supply materials, imaging manuals, and laboratory handling manuals.
Assist with the informed consent process and support and advocate for research subject safety.
Facilitate pre-study and site qualification activities, study initiation, monitoring visits, and study close-out activities.
Collect, process, and ship laboratory specimens.
Comply with Innovo, clinic, and sponsor policies and standard operating procedures, as well as applicable regulatory requirements and guidelines.
Perform additional duties as assigned.