The Clinical Research Associate III is responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete and verifiable from source documents. The CRA is also the primary link between Romark and the Investigational Sites, acting as a site manager ensuring that clinical trials are conducted compliance with the currently approved protocol/amendment(s), with GCP, the applicable regulatory requirement(s), and the Romark Standard Operating Procedures.
1) Monitoring of investigational sites as per CFR21 part 312, ICH GCP and the Clinical Monitoring Plan for each study. Specific duties include:
a) Site Selection:
Assist with site identification, site feasibility assessment, and selection of investigational sites.
b) IRB & Regulatory Submission:
In collaboration with the CTA prepare site essential documents, and participate in the IRB submission and approval processes.
c) Study Initiation:
Train investigators on the sponsor and regulatory requirements for conducting the study. Ensure the site has all supplies to perform the trial.
Ensure recruitment of participants as per the site target. Take positive action to encourage site recruitment, and report recruitment issues promptly to the study management team. Prepare site specific recruitment plan(s) as appropriate and update as required.
e) Monitoring Visits:
Independently perform Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Site Close-out Visits according to the Clinical Monitoring Plan. Ensure the trial is conducted according to the protocol, ICH GCP, and applicable guidelines & regulatory requirements.
f) Patient Safety:
Ensure rights & wellbeing of trial participants are protected, including consent form review, patient eligibility confirmation, protocol compliance including investigational drug compliance, and review of Adverse Events/SAEs. Ensure safety issues are promptly reported to the Medical Affairs Department.
g) Protocol deviations and violations:
Identify and document protocol deviations and violations and work with the site to develop appropriate CAPA plan. Report deviations and violations to the study management team.
h) Data Collection:
Verify trial data are accurate and complete, ensure CRF data are completed correctly and data queries are completed appropriately and promptly by site staff.
i) Site Documentation:
Review site files, in house and at site to ensure all essential documents as per ICH GCP and FDA CFR21 parts 50, 54, 56 and 312 are present and complete.
j) Investigational Medicinal Product (IPM):
Ensure all IMP is appropriately stored, dispensed, accounted for and reconciled as per the Clinical Monitoring Plan and the Protocol.
k) Site communication:
Serve as primary contact for investigative site communication for each assigned site.
2) Provide status updates during the project team meetings
3) Participate in investigator meetings as appropriate, including preparing and presenting presentations
4) Ensure project tracking systems are updated to reflect work performed at clinical trial site.
5) Assist with the development of protocols, CRFs, Clinical Monitoring Plan, study specific forms and tracking tools as per the needs of the study
6) Assist the sites in the preparation of responses to audit findings
7) Participate in activities of the Clinical Operations Department, including presentation at departmental meetings and assisting with development of clinical processes and SOPs.
8) Represent Romark at industry events (conferences, professional association, etc.). Be mindful of the role of ambassador for Romark when conducting day to day business.
9) Assist in training, coaching and mentoring of junior Clinical Operations department staff
10) Other duties as assigned
Education and/or Experience
- Bachelor’s degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field. Equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis.
- 2 - 4 years of CRA experience in pharma, biotech or CRO.
- In depth knowledge of clinical research regulations governing the conduct of clinical trials and quality standards
- Proficient with routine medical/scientific terminology.
- Excellent understanding of clinical data flow. Prior experience with EDC is ideal.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Ability to write reports and business correspondence.
- Ability to deal with confidential information.
- Ability to work as part of a team and independently with minimal supervision.
- Ability to problem-solve is required
- Strong integrity and work ethic are critical.
- Willing and able to travel up to 80%, including internationally, as required.
- Technical Capability
- Communication Proficiency
- Project Management
- Collaboration Skills
- Problem Solving Skills
- Critical thinking
- Ethical Conduct
Romark Core Values
- Vision - Big vision, no limits; purpose-driven; ability to identify potential problems or impediments and to see through them
- Competence - Exceptional knowledge and understanding of the work we are called to do; exceptional critical thinking skills
- Ingenuity - Original, creative, clever, innovative, perceptive and/or intuitive in solving problems or meeting challenges
- Courage - Willingness to take calculated risks to accomplish a noble mission
- Passion - Intense compelling enthusiasm or desire to achieve our calling/fulfill our purpose
- Integrity - Having a clear vision and understanding of that which is right and doing it; being faithful to patients and healthcare professionals
- Relationships - Trusted business partners, engaging others with professionalism, grace and respect in valued long-term relationships
- Personal Responsibility - Leadership, dependability, doing our jobs and going beyond the call to ensure success of the organization
- Respect -Humility; exhibiting special appreciation for medicines, for our work, for the responsibilities and opportunities with which we have been entrusted
- Perseverance - "In it to win it" – steadfast despite difficulty or delay
- Excellence - Being outstanding or extremely good in everything we do
Bachelors or better in Biology.
Bachelors or better in Nursing.
Bachelors or better in Pharmacy.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.