What does a senior clinical research associate do?
A Senior Clinical Research Associate performs and coordinates all aspects of the clinical monitoring and site management process. They design, implement, and monitor clinical trials.
Senior clinical research associate responsibilities
Here are examples of responsibilities from real senior clinical research associate resumes:
- Manage a consultant to review scientific support and create dossiers on each product that make health claims in the EU.
- Interact with FDA and other regulatory authorities to manage and facilitate approval of regulatory submissions.
- Monitor U.S. sites in accordance with ICH and GCP guidelines.
- Maintain investigators and subjects files, review investigators files for compliance with GCP and FDA regulations, review drug utilization records.
- Verify informed consent procedures and protocol requirements base on applicable regulatory requirements to ensure protection of study patients.
- Provide site management for both therapeutic and supportive care oncology protocols that are complex and require knowledge in advance therapeutic areas.
- Develop the clinical strategy and investigational plan for an IDE.
- Update study and patient status information and serves as (CTMS) resource for PM/CTL.
- Monitor recruitment and data quality while on site and remotely through EDC systems and direct site communication.
- Assist in maintaining accurate and up to date study information within CTMS and other relevant tracking systems.
- Sponsor and CRO attend SIV and receive kudos for knowledge of complicate protocol and high level of professionalism.
- Communicate with sites regarding issues such as protocol, patient participation, CRF completion, and other study-relate issues.
- Coordinate and train the staff for the internal audit of clinical trial documents transfer from the CRO to the sponsor site.
- Conduct CRA and protocol-specific training and development activities.
- Participate in CRA protocol specific training and development.
Senior clinical research associate skills and personality traits
We calculated that 11% of Senior Clinical Research Associates are proficient in Patients, Informed Consent, and Oncology. They’re also known for soft skills such as Communication skills, Interpersonal skills, and Leadership skills.
We break down the percentage of Senior Clinical Research Associates that have these skills listed on their resume here:
- Patients, 11%
Verified informed consent procedures and protocol requirements based on applicable regulatory requirements to ensure protection of study patients.
- Informed Consent, 6%
Managed the financial approval process for Clinical Site Agreements, Informed Consent Customization Site Regulatory Package, and IRB/IEC application preparation/submission.
- Oncology, 5%
Provided site management for both therapeutic and supportive care oncology protocols that were complex and required knowledge in advanced therapeutic areas.
- CRA, 5%
Attended Investigator meetings and presented CRA responsibilities to audience.
- Site Management, 5%
Created and maintained documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports.
- Field Training, 4%
Acted as a mentor to new associates for purposes of field training.
"patients," "informed consent," and "oncology" are among the most common skills that senior clinical research associates use at work. You can find even more senior clinical research associate responsibilities below, including:
Communication skills. One of the key soft skills for a senior clinical research associate to have is communication skills. You can see how this relates to what senior clinical research associates do because "natural sciences managers must be able to communicate clearly with a variety of audiences, such as scientists, policymakers, and the public." Additionally, a senior clinical research associate resume shows how senior clinical research associates use communication skills: "manage site tmf contents and work with sites to ensure communication requirements between site and irb are adhered to. "
Interpersonal skills. Many senior clinical research associate duties rely on interpersonal skills. "natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals," so a senior clinical research associate will need this skill often in their role. This resume example is just one of many ways senior clinical research associate responsibilities rely on interpersonal skills: "demonstrated excellent interpersonal skills as liaison between site personnel and clients. "
Leadership skills. senior clinical research associates are also known for leadership skills, which are critical to their duties. You can see how this skill relates to senior clinical research associate responsibilities, because "natural sciences managers must be able to organize, direct, and motivate others." A senior clinical research associate resume example shows how leadership skills is used in the workplace: "provided leadership and coordinated the efforts of cra team members related to investigator meetings. "
Problem-solving skills. A big part of what senior clinical research associates do relies on "problem-solving skills." You can see how essential it is to senior clinical research associate responsibilities because "natural sciences managers use scientific observation and analysis to find answers to complex technical questions." Here's an example of how this skill is used from a resume that represents typical senior clinical research associate tasks: "assisted team in all aspects of data collection and query resolution. "
Time-management skills. A commonly-found skill in senior clinical research associate job descriptions, "time-management skills" is essential to what senior clinical research associates do. Senior clinical research associate responsibilities rely on this skill because "natural sciences managers must be able to perform multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule." You can also see how senior clinical research associate duties rely on time-management skills in this resume example: "coordinated with existing sites and initiated 10 others within one month to meet enrollment/data collection target deadlines. "
The three companies that hire the most senior clinical research associates are:
- Laboratory Corporation of America Holdings364 senior clinical research associates jobs
- QuintilesIMS285 senior clinical research associates jobs
- Merck106 senior clinical research associates jobs
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Compare different senior clinical research associates
Senior clinical research associate vs. Study director
Technically, a study director carries out scientific responsibilities for protocol design or study plan and approval. Study directors supervise the gathering, analysis, interpretation, documentation, and reporting of data results. They handle the matriculation of students with regard to data management system development. Working with the computer systems team is part of their duties so they will be able to establish a data management system in tracking the study participants. They also support the toxicology team or group on different project teams.
There are some key differences in the responsibilities of each position. For example, senior clinical research associate responsibilities require skills like "patients," "oncology," "cra," and "site management." Meanwhile a typical study director has skills in areas such as "toxicology," "study design," "project management," and "data analysis." This difference in skills reveals the differences in what each career does.
Study directors earn the highest salaries when working in the health care industry, with an average yearly salary of $87,246. On the other hand, senior clinical research associates are paid more in the pharmaceutical industry with an average salary of $94,732.The education levels that study directors earn slightly differ from senior clinical research associates. In particular, study directors are 4.4% more likely to graduate with a Master's Degree than a senior clinical research associate. Additionally, they're 5.8% more likely to earn a Doctoral Degree.Senior clinical research associate vs. Study coordinator
Study coordinators oversee the entire process of clinical research from its inception to its completion. The coordinators make certain that human subjects are safe and well-protected. They identify the eligibility of the subject through clinical record screening and medical information extracting. It is their responsibility to maintain the regulatory documents based on the requirements of the Food and Drug Administration (FDA). They should develop skills and knowledge in clinical trials, study protocol, and patient care.
While some skills are similar in these professions, other skills aren't so similar. For example, resumes show us that senior clinical research associate responsibilities requires skills like "cra," "site management," "field training," and "clinical sites." But a study coordinator might use other skills in their typical duties, such as, "data entry," "research data," "patient care," and "excellent interpersonal."
Study coordinators earn a lower average salary than senior clinical research associates. But study coordinators earn the highest pay in the health care industry, with an average salary of $50,589. Additionally, senior clinical research associates earn the highest salaries in the pharmaceutical with average pay of $94,732 annually.Average education levels between the two professions vary. Study coordinators tend to reach similar levels of education than senior clinical research associates. In fact, they're 1.2% more likely to graduate with a Master's Degree and 5.8% less likely to earn a Doctoral Degree.Senior clinical research associate vs. Senior program coordinator
A senior program coordinator is primarily in charge of spearheading and managing programs, ensuring everything runs smoothly and efficiently. Their responsibilities revolve around participating in setting goals and objectives, securing funding and sponsors, overseeing the workforce, and even establishing guidelines. They may also facilitate communication within the company and liaise with external parties. Furthermore, as a senior program coordinator, it is essential to lead and encourage the teams to reach goals, all while implementing the company's policies and regulations, including its vision and mission.
There are many key differences between these two careers, including some of the skills required to perform responsibilities within each role. For example, a senior clinical research associate is likely to be skilled in "patients," "oncology," "cra," and "site management," while a typical senior program coordinator is skilled in "alumni," "excellent organizational," "powerpoint," and "sr."
When it comes to education, senior program coordinators tend to earn similar degree levels compared to senior clinical research associates. In fact, they're 1.6% more likely to earn a Master's Degree, and 3.9% more likely to graduate with a Doctoral Degree.Senior clinical research associate vs. Clinical project manager
A clinical project manager specializes in developing and organizing clinical trials. Their responsibilities revolve around planning and coordinating with all necessary personnel and experts, scheduling meetings, and preparing necessary documentation, ensuring compliance with all laws and regulations. Moreover, a clinical project manager must devise strategies and train all staff, develop protocols and guidelines, coordinate with vendors and suppliers, evaluate staff and verify documentation, and assist in all activities to ensure that every process aligns with the project's agenda. Should there be any issues or concerns, a clinical project manager must conduct corrective measures right away.
Types of senior clinical research associate
Updated January 8, 2025
