113 Researchers jobs in Pittsburgh

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.**
Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a _Pharmacovigilance Data Analysis Manager_ like you.
Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes, ensuring compliance and alignment with business needs.
**What your responsibilities will be**
+ Lead and coordinate safety data analysis for aggregate reports preparation, signal management and ad hoc requests.
+ Support drug safety systems through business administration tasks, including database configuration updates, submission rules management and testing with regulatory authorities.
+ Serve as a subject matter expert in delivering and evaluating cost-effective, sustainable solutions that meet business requirements.
+ Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/ technical specifications and process flow diagrams.
+ Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
+ Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
+ Act as the primary PV contact for IT-related PV projects.
+ Drive Innovation through AI in Pharmacovigilance: Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI-driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross-functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.
**Who you are**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ You have a bachelor's degree in Health Sciences (pharmacy, nursing, medicine, veterinary, etc) or Bioscience (biochemistry, biotechnology, biology, etc). Additional training and/or experience in bioinformatics/biostatistics or data analysis tools (such as R or Power BI).
+ You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance data bases.
+ You have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data administration.
+ You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
+ Familiarity with reporting tools such as Business Objects is strongly preferred.
+ You have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a plus.
+ You speak fluent Spanish and English.
+ You are proven self-starter with strong work ethic and the ability to exercise good judgment.
+ You must be proactive, results oriented and have strong attention to detail.
+ Strong organizational, analytical and problem-solving skills with the ability to make structured decisions on a routine basis.
+ Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
+ You possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
+ Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines.
**What we offer**
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!
We look forward to receiving your application!
**We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.**
Grifols is an equal opportunity employer.
**Flexible schedule:** Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
**Benefits package**
**Contract of Employment:** Permanent position
**Flexibility for U Program:** Hybrid
**Location:** Sant Cugat del Vallès (preferably) / Other locations as Los Angeles, Clayton or Dublin will be considered
more about Grifols
**Req ID:** 531655
**Type:** Indefinido tiempo completo
**Job Category:** I + D

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding.**
Help us lead one of the world's largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That's why we need a _Pharmacovigilance Data Analysis Manager_ like you.
Role Mission: Provide operational support for global pharmacovigilance activities related to Grifols' investigational and marketed products. Ensure high-quality pharmacovigilance deliverables that comply with global regulatory reporting timelines. Manage project implementation and execution of safety systems, including ongoing business support and continuous improvement initiatives. Act as a key liaison with IT system administrators to validate and test system changes, ensuring compliance and alignment with business needs.
**What your responsibilities will be**
+ Lead and coordinate safety data analysis for aggregate reports preparation, signal management and ad hoc requests.
+ Support drug safety systems through business administration tasks, including database configuration updates, submission rules management and testing with regulatory authorities.
+ Serve as a subject matter expert in delivering and evaluating cost-effective, sustainable solutions that meet business requirements.
+ Manage documentation related to PV systems and applications, including SOPs, WPs, user requirements, functional/ technical specifications and process flow diagrams.
+ Drive change management initiatives to ensure smooth adoption of new processes and support the integration of new applications within the PV team.
+ Collect, prioritize and plan system improvements based on user feedback, while ensuring compliance with regulatory requirements.
+ Act as the primary PV contact for IT-related PV projects.
+ Drive Innovation through AI in Pharmacovigilance: Stay at the forefront of artificial intelligence advancements to identify and evaluate innovative technologies and processes that can enhance pharmacovigilance operations. This includes proactively assessing AI-driven tools and methodologies to improve signal detection, case processing, data analysis and regulatory compliance. Collaborate cross-functionally to pilot and implement solutions that increase efficiency, accuracy, and strategic value in safety monitoring.
**Who you are**
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
+ You have a bachelor's degree in Health Sciences (pharmacy, nursing, medicine, veterinary, etc) or Bioscience (biochemistry, biotechnology, biology, etc). Additional training and/or experience in bioinformatics/biostatistics or data analysis tools (such as R or Power BI).
+ You have at least 4 years of pharmacovigilance experience including management of pharmacovigilance data bases.
+ You have proven knowledge of Good Pharmacovigilance Practices; existing legislation, regulations, guidelines, medical coding and safety-data administration.
+ You are proficient in Windows and MS Office (Excel, PowerPoint, Visio, Word).
+ Familiarity with reporting tools such as Business Objects is strongly preferred.
+ You have knowledge of E2b (R2) and E2b (R3) and to be familiarity with medical terminology, MedDRA, WhoDrug are a plus.
+ You speak fluent Spanish and English.
+ You are proven self-starter with strong work ethic and the ability to exercise good judgment.
+ You must be proactive, results oriented and have strong attention to detail.
+ Strong organizational, analytical and problem-solving skills with the ability to make structured decisions on a routine basis.
+ Strong interpersonal skills with the ability to interact and collaborate with personnel at all levels in a team environment.
+ You possess strong technical writing and communication skills with ability to create and present design proposals, test scripts, execute training sessions and conduct effective meetings.
+ Ability to effectively prioritize and manage multiple tasks to ensure successful completion targeted deadlines.
**What we offer**
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at If you are interested in joining our company and you have what it takes for such an exciting position, then don't hesitate to apply!
We look forward to receiving your application!
**We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.**
Grifols is an equal opportunity employer.
**Flexible schedule:** Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
**Benefits package**
**Contract of Employment:** Permanent position
**Flexibility for U Program:** Hybrid
**Location:** Sant Cugat del Vallès (preferably) / Other locations as Los Angeles, Clayton or Dublin will be considered
more about Grifols
**Req ID:** 531655
**Type:** Indefinido tiempo completo
**Job Category:** I + D

Job Description

Job Description

Research Associate/ Senior Research Associate

Location: Durham, North Carolina 27713

Position type: Full Time

About TCRCure Biopharma Corp.

TCRCure is a clinical-stage biotechnology startup that brings novel TCR-T and CAR-T cell therapies to patients around the world. We focus on treating solid tumors with personalized cancer immunotherapies. Over the past years, we have developed 9 pipelines, built 3 platforms and launched 4 T cell therapies. Our team of scientists and engineers leverage their expertise in molecular engineering, TCR repertoire analysis, cancer immunology, and cell and gene therapy to advance our growing pipeline of next-generation therapies.

Job Description:

Our research team in RTP is seeking a highly motivated individual to perform hands-on laboratory work. The role will have rapidly evolving priorities and ever-changing workloads, so adaptability is a must. We value teamwork and collaboration, and effectively working with scientists and other associates in the group to help our product development succeed is expected. Responsibilities include but are not limited to: developing strategies for novel TCR-/CAR-T cell therapies; planning, and executing in vitro functional assays with human and mouse T cells; working independently and cross-functionally with the in vivo development team to validate the in vivo efficacy of our novel products; performing molecular biology experiments such as PCR, cloning, DNA/RNA extraction, and bacterial transformation etc. The candidate will prepare technical reports and presentations to illustrate and explain experiments, data, and conclusions.

Position Requirements:

- B.S. or M.S. (M.S. preferred) in Biological Sciences or a related scientific discipline,

·    Research Associate: 1 year minimum experience, industry experience preferred

·    Senior Research Associate: 3 years minimum experience, industry experience preferred; highly matched with the job requirements

- Hands-on experience with mammalian cell culture, T cell and other primary leukocyte culture, cell transfection, retro-/lenti-virus transduction; previous experience with CAR-T or immunotherapy is preferred

- Experience with ELISA and flow cytometry techniques. Experience with multiparametric flow cytometry is strongly preferred

- Experience with animal handling, sampling, and dosing is desired

- Working knowledge and broad understanding of immunology and adoptive cell therapy is required

- Working knowledge of molecular biology and cloning is required

- Proficiency with standard software and statistical analysis (e.g., Microsoft Office, Graph Pad Prism), FlowJo experience is strongly preferred

- Strong record-keeping skills; highly organized and detail-oriented

- Basic understanding of GLP, GDP and GMP requirements

- Excellent communication and interpersonal skills for working closely with a diverse array of team members

-Comfortable and efficient in a fast-paced, dynamic, and growing environment

To Apply:

TCRCure Biopharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. TCRCure Biopharma complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

If you are interested in applying for this opportunity, please submit your resume and cover letter. All submissions will be evaluated, and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
**The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.**
**Primary responsibilities include:**
+ **Tracking study specific tasks and progress of the trial.**
+ **Performing regulatory document review and approval for IP release.**
+ **Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings).**
+ **Conducting monitor training.**
+ **Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies.**
+ **Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes.**
+ **Collaborating with data management to resolve queries.**
+ **Facilitating investigator site payments, as applicable.**
+ **Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation.**
+ **Assisting in evaluation of vendor performance during conduct of the study.**
+ **Acquiring a basic knowledge of the therapeutic area and product.**
+ **Obtaining a complete understanding of all trial-related documents and operational procedures.**
+ **Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes.**
+ **Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable**
+ **Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).**
+ **Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.**
+ **Preparing accurate and complete meeting minutes for various meetings.**
+ **Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy.**
+ **Assists with effective and timely audit/inspection responses.**
**For studies monitored in house by Grifols, additional responsibilities may include:**
+ Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits.
+ Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up.
+ Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance.
+ Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity.
+ Reconciles clinical supplies and drug accountability records at study sites.
+ Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required.
+ Reviews, clarifies, and obtains, data changes via query resolutions with site personnel.
+ Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities.
**Additional responsibilities:**
Assists in the development of study timelines and ensures compliance. Assists in the management of vendors. Prepares key reports and documents on progress of study for study manager. Monitors adherence to the regulatory document collection process. Interacts with data management, safety, regulatory personnel, and other functional groups. Assists team members in reviewing data listings and writing queries. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Reviews study specific ICF(s) for compliance with ICH/GCP and company SOPs. Participates in CRF development and completion.
**Knowledge, Skills, and Abilities:**
Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Good knowledge of therapeutic area assigned. Strong knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel.
**Requirements:**
+ Associate's degree in a life science field required. Bachelor's degree in a life science field preferred.
+ Typically requires 2 years of experience in clinical research, including a minimum of 1 year field monitoring experience (e.g., independent monitoring, co-monitoring, accompanied site visits).
+ Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
**Occupational Demands:**
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.**
Learn more about Grifols ( ID:** 531343
**Type:** Regular Full-Time
**Job Category:** Clinical Trials

Our client is seeking a highly experienced and dedicated Senior Clinical Research Associate (CRA) to join their dynamic pharmaceutical team in Raleigh, North Carolina, US . This is a critical role responsible for ensuring the quality, integrity, and successful execution of clinical trials across various therapeutic areas. The Senior CRA will oversee study sites, ensuring adherence to protocols, regulatory requirements (FDA, ICH-GCP), and company standard operating procedures. Key responsibilities include site selection and initiation, conducting routine monitoring visits (on-site and remote), data verification, source document review, and ensuring timely resolution of study-related issues. You will also play a vital role in training and mentoring junior CRAs, contributing to the overall development and success of the clinical research department. The ideal candidate will possess a strong understanding of drug development processes, excellent communication and interpersonal skills, and the ability to manage multiple priorities effectively in a fast-paced environment. A Bachelor's degree in a life science, nursing, or related field is required, along with a minimum of 5 years of direct CRA experience. Advanced degrees and specific therapeutic area experience, particularly in oncology or immunology, will be highly advantageous. You will be expected to travel to study sites as needed, approximately 50-60% of the time. This position offers a competitive salary, comprehensive benefits package, and opportunities for professional growth within a leading pharmaceutical organization. If you are a meticulous and results-oriented CRA looking to make a significant impact, we encourage you to apply.

A leading pharmaceutical innovator, situated in Raleigh, North Carolina, US , is actively searching for a dedicated and detail-oriented Clinical Research Associate (CRA) to contribute to groundbreaking clinical trials. In this critical role, you will be instrumental in ensuring the integrity, accuracy, and efficiency of clinical research studies, adhering strictly to Good Clinical Practice (GCP) guidelines and regulatory requirements. Your responsibilities will encompass site selection, initiation, monitoring, and close-out visits for clinical trial sites. You will meticulously verify patient safety and rights, data accuracy and integrity, and the overall integrity of the trial conduct. This involves performing source data verification, ensuring adherence to the protocol, and managing investigational product. You will serve as the primary point of contact between the sponsor and the clinical trial sites, fostering strong working relationships and providing essential training and support to site staff. The ideal candidate possesses a strong understanding of drug development processes and clinical trial methodologies. A Bachelor's degree in a life science, nursing, or a related field is required; advanced degrees are a plus. Excellent communication, interpersonal, and organizational skills are paramount, as is the ability to travel frequently to investigative sites. Experience as a CRA or in a related clinical research role is mandatory. If you are passionate about advancing healthcare through rigorous scientific research and possess the necessary qualifications, we invite you to apply for this exciting opportunity.

Our client, a leading pharmaceutical company, is seeking a meticulous and experienced Clinical Research Associate (CRA) to contribute to groundbreaking medical research from their base in Raleigh, North Carolina, US . As a CRA, you will play a crucial role in ensuring the quality and integrity of clinical trials by monitoring study sites, verifying data accuracy, and ensuring compliance with protocols and regulatory requirements. This is an exciting opportunity to be at the forefront of drug development and patient care.

Key responsibilities include:

• Performing site qualification, initiation, monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) guidelines and study protocols.
• Monitoring patient safety and data integrity at assigned clinical trial sites.
• Ensuring all study-related documentation is accurate, complete, and maintained in a timely manner (e.g., Investigator Site Files, Case Report Forms).
• Verifying source data against Case Report Forms (CRFs) and electronic data capture (EDC) systems.
• Communicating effectively with investigators, site staff, and study sponsors regarding study progress, issues, and resolutions.
• Identifying and reporting deviations from protocols, SOPs, or regulatory requirements.
• Providing training and support to site personnel on study procedures and regulatory requirements.
• Managing site relationships and ensuring adherence to study timelines and objectives.
• Participating in study team meetings and contributing to the overall success of the clinical trial.
• Staying up-to-date with relevant therapeutic areas, industry best practices, and regulatory guidelines.

The ideal candidate will possess a Bachelor's degree in a life science, nursing, or a related field. At least 3 years of experience as a Clinical Research Associate or in a similar clinical trial monitoring role is required. Thorough understanding of GCP, ICH guidelines, and FDA regulations is essential. Excellent organizational, communication, and interpersonal skills are crucial. Ability to travel extensively to assigned sites is a requirement for this role. If you are passionate about clinical research and committed to upholding the highest standards of data quality and patient safety, we encourage you to apply.

Our client, a premier biopharmaceutical company at the forefront of medical advancements, is seeking an experienced Clinical Research Associate (CRA) to contribute to groundbreaking clinical trials in Raleigh, North Carolina, US . This vital role will focus on ensuring the quality, integrity, and compliance of clinical research data according to Good Clinical Practice (GCP) guidelines and regulatory requirements. The CRA will be responsible for site selection, initiation, monitoring, and close-out visits, ensuring that all study protocols are adhered to and that patient safety is paramount. Key duties include verifying data accuracy through source document verification, ensuring proper drug accountability, and maintaining comprehensive study documentation. The ideal candidate will possess a meticulous attention to detail, strong organizational skills, and the ability to effectively manage multiple tasks and priorities. You will serve as the primary point of contact for clinical sites, providing guidance and support to investigators and site staff, fostering collaborative relationships to ensure successful trial execution. This position requires a deep understanding of clinical trial processes, regulatory affairs, and medical terminology. You will play a critical role in the timely completion of trials, contributing directly to the development of life-saving therapies. A Bachelor's degree in a life science, nursing, or a related field is required, coupled with at least 3-5 years of direct experience as a CRA. A solid understanding of ICH-GCP guidelines and experience with electronic data capture (EDC) systems are essential. Excellent communication and interpersonal skills are crucial for effective site management and team collaboration. Travel to clinical sites will be a significant component of this role. If you are passionate about advancing healthcare and possess the expertise to ensure the highest standards in clinical research, we encourage you to apply.

Our client, a rapidly growing pharmaceutical company dedicated to advancing medical treatments, is actively recruiting a Senior Clinical Research Associate (CRA) to join their esteemed clinical operations team in Raleigh, North Carolina, US . This pivotal role involves managing and monitoring clinical trials to ensure adherence to protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The Senior CRA will be responsible for site selection, initiation, monitoring, and close-out activities, ensuring data integrity and patient safety throughout the trial lifecycle. You will serve as the primary liaison between the sponsor and clinical trial sites, providing essential support and guidance to investigators and study coordinators.

To be successful in this role, candidates should possess a Bachelor's degree in a life science, nursing, or a related field; a Master's degree is a plus. A minimum of 5 years of experience as a Clinical Research Associate in the pharmaceutical or biotech industry is required, with significant experience in managing multiple clinical trials concurrently. Thorough knowledge of ICH guidelines, GCP, FDA regulations, and clinical trial methodology is mandatory. Excellent organizational, problem-solving, and communication skills are essential. The ability to travel up to 60% is expected for site visits. Proficiency with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is necessary. This is an excellent opportunity for a dedicated CRA to contribute to cutting-edge research and make a tangible difference in patient lives within a supportive and collaborative environment in Raleigh, North Carolina, US .