1,886 Senior Clinical Research Associate jobs in the United States

Responsible for the clinical monitoring activities for assigned clinical trial sites in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs to the most rigorous standards of quality and timely delivery.

Essential functions:

• Support clinical trial site feasibility.
• Conduct all aspects of clinical monitoring for clinical trials including site visits for qualification, initiation, routine monitoring and close-out.
• Conduct all aspects of site management as prescribed in the clinical trial specific functional plans.
• Review progress of clinical trials, especially patient recruitment and clinical trial data capture, and initiate appropriate actions to achieve objectives.
• Support the maintenance of the Investigator Site Files and Trial Master Files.
• Prepare accurate and timely monitoring visit reports.

Secondary functions:

• Maintain clinical trial tracker.
• Organize and present content at Investigator Meetings.
• Participate in the development of Case Report Forms and clinical trial documents.
• Act as contact for clinical trial supplies and other suppliers (vendors).
• Prepare and review Standard Operations Procedures and Working Instructions as well as template documents.

Competencies:

• Excellent communication (written/verbal) skills.
• Positive attitude and willingness to learn and contribute in a team.
• Excellent organizational skills to work efficiently, good time management.
• Exceptional attention to detail.
• Team player with excellent negotiation and conflict resolution skills.
• Demonstrates ability to take initiative and work independently.
• Ability to prioritize and adapt quickly in a fast-paced and changing industry.
• Outside the box thinking and a high degree of flexibility in an environment which is marked by a constant striving for excellence.

Work environment:

This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.

Physical demands:

• Communicating verbally expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
• Hearing the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
• Keyboarding entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
• Lifting raising or lowering an object (up to 25 lbs) from one level to another (includes upward pulling). Carrying is to transport an object usually by holding it in the hands or arms but may occur on the shoulder.
• Near Visual Acuity clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
• Pushing exerting force upon an object so that the object moves away from the object.
• Pulling exerting force upon an object so that the object moves toward the force.
• Sitting remaining in a sitting position for at least 50% of the time.
• Standing/Walking remain on one's feet in an upright position at a workstation.
• Stooping occasional bending the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

Travel required: Travel is an essential function of the job (>75%).

Required education and experience:

• Bachelor's degree preferably in life science or nursing, or you have a comparable education.
• 5 - 7 years of on-site monitoring experience in the pharmaceutical/biotechnology industry.
• Understanding of medical oncology terminology and science.
• Excellent communication and interpersonal skills, with the ability to build strong relationships with trial site staff and internal team members.
• Strong organizational skills, with the ability to manage multiple projects and meet deadlines.
• In-depth knowledge of ICH-GCP, FDA, EMA and applicable local regulations and laws.
• Valid Driver's license.
• Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS)

Preferred education and experience:

• Excellent English knowledge (written and spoken)

Work authorization/security clearance requirements:

Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.

Affirmative Action/EEO statement:

Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medical conditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Other duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. This job description may not cover all duties that take place on a daily basis and may be changed as business needs change. Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.

The Clinical Research Associate will work cooperatively with the research team to design and execute clinical research studies. Studies involve clinical stem cell and platelet rich plasma work in the area of Regenerative Orthopedics. The incumbent will co-author studies and be involved in educational seminars on these topics. Responsibilities Include: Leads execution & control of research study. Responds to grants and proposals in support of the advancement of clinical research. Manages and ensures completion of study activities per protocol. Determines & registers participants. Conducts compliance measures. Manages conduct of experimental tests & procedures. Closely monitors & documents patient's experience and partners with physicians in modifying tests & treatment schedule. Manages project data including processing, accuracy, analysis & evaluation of data ensuring that results meet project information and deliverable objectives. Creates, reviews, analyzes, interprets, and prepares progress & final reports. This opportunity offers a flexible schedule and the opportunity to work as a consultant or direct hire based on experience. ROSM provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Research, Analyst, and Information Technology Industries Medical Practices Referrals increase your chances of interviewing at Regenerative Orthopedics & Sports Medicine by 2x Get notified about new Senior Clinical Research Associate jobs in Washington, DC . Washington, DC $64,188.80-$06,995.20 2 weeks ago Associate Director, Business Development Clinical Research Germantown, MD 101,000.00- 121,000.00 1 week ago Lab Manager, Department of Psychology - Georgetown University College of Arts and Sciences Senior Clinical Project Manager-IVD/Neuro Washington, DC 140,000.00- 150,000.00 2 days ago Silver Spring, MD 88,600.00- 150,800.00 1 week ago Washington, DC 85,404.80- 142,334.40 7 hours ago Immunology Research Associate II - Senior Research Associate Silver Spring, MD 80,000.00- 110,000.00 6 hours ago Washington, DC 110,000.00- 115,000.00 1 month ago AI & Data Manager - Life Sciences R&D Clinical (Pharma) McLean, VA 130,800.00- 241,000.00 2 weeks ago Manager, CRA Strategy and Program Management RN Clinical Program Coordinator - Heart Institute Research Admin Washington, DC 82,347.20- 137,238.40 1 week ago Clinical Research Nurse Coordinator 1 - Women's Silver Spring, MD 77,334.00- 116,000.00 2 days ago (RN) Clinical Research Nurse Coordinator I (RN) Clinical Research Nurse Coordinator I Cardiology Silver Spring, MD 77,334.00- 116,000.00 2 days ago Silver Spring, MD 37.18- 55.77 2 weeks ago Clinical Research Nurse Coordinator 1 - Schar Heart & Vascular Rockville, MD 90,000.00- 120,000.00 1 month ago Gaithersburg, MD 59,100.00- 87,900.00 3 weeks ago Clinical Research Associate (DMD/neuromuscular) Junior Scientist (Human Research Protections) Arlington, VA 60,000.00- 85,000.00 1 week ago Research Assistant I - Suicide CRP Initiative Washington DC-Baltimore Area 4 months ago Washington, DC 69,659.20- 116,084.80 1 week ago Clinical Research Associate 2 - Qualitative Research Bethesda, MD 57,650.00- 76,000.00 2 weeks ago Washington, DC 50,252.80- 83,761.60 2 weeks ago Gaithersburg, MD 45,500.00- 66,000.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Job DescriptionResponsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.Essential Duties And ResponsibilitiesParticipate and assist in design and preparation of protocols and case report forms.Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.Participate in the evaluation of potential clinical sites according to established criteria of acceptability.Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.Assist with the maintenance of clinical archive and electronic files.Other tasks as assigned.RequirementsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.BA, BS, RN, BSN or equivalentBasic knowledge and adherence to GCPs5+ years of clinical research experienceStrong attention to detailAbility to multi-taskUnquestionable integrity and highest ethical standardsExcellent written and verbal communication skillsSelf-motivated, assertive, and driven

Get AI-powered advice on this job and more exclusive features. Direct message the job poster from General Oncology This position is for a senior clinical research associate (senior CRA). The position also involves certain other trial-related tasks, such as filing to and maintaining the eTMF. About General Oncology General Oncology is a biopharmaceutical company focused on developing new treatments for metastatic and refractory cancers. Our clinical asset, GO-4, is a proprietary drug combination for the treatment of BRCA-related cancers, including stage IV pancreatic cancer, and is headed to phase 2. We are also developing an extensive pipeline of ultra-high potency small molecule drugs for other cancers. Our team is collegial, passionate about our work, and rapidly growing. Responsibilities Clinical monitoring Maintaining the eTMF Site activation and closing Qualifications At least 5 years of oncology CRA experience Must have experience with phase 1, phase 2, and phase 3 Meticulous attention to detail Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Research and Administrative Referrals increase your chances of interviewing at General Oncology by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Get notified about new Clinical Research Associate jobs in Newton, MA . Boston, MA $50,000.00-$5,000.00 2 days ago Boston, MA 90,000.00- 100,000.00 1 day ago Clinical Trial Associate (Boston, MA Based) In-vivo Research Associate, Immunology and Pharmacology Clinical Research Assistant I- Baby Steps Clinical Research Coordinator - Cutaneous Clinical Research Assistant I-Endocrinology Department Massachusetts, United States 3 months ago Research Associate – Biology Vivo/InVitro RESEARCH TECHNICIAN, Psychological & Brain Sciences RESEARCH TECHNICIAN, Psychological & Brain Sciences Clinical Research Assistant I- Baby Steps Clinical Research Coordinator - Cellular Immunotherapy We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr

Key Accountabilities:

Start-up (from site identification through pre-initiation):

Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.

• Build relationships with investigators and site staff.

• Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:

-Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
-Conduct remote Qualification Visits (QVs).

• Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.

• Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.

• Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.

• Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.

• Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.

• Forecast, develop, manage, and revise plans and strategies for:

-IRB/IEC and MoH / RA submission/approval,
-Site activation,
-Patient recruitment & retention.

• Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.

• Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.

• Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.

• Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections

• Work in a self-driven capacity, with limited need for oversight.

• Proactively keep manager informed about work progress and any issues.

Maintenance (from initiation through close out):

Act as Parexel's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.

• Build relationships with investigators and site staff.

• Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.

• Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.

• Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.

• Address/evaluate/resolve issues pending from the previous visit, if any.

• Follow-up on and respond to appropriate site related questions.

• Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.

• Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.

• Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.

• Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.

• Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.

• Conduct remote visits/contacts as requested/needed.

• Generate visit/contact report.

• Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.

• Assess & manage test article/study supply including supply, accountability and destruction/return status.

• Review & follow-up site payment status.

• Follow-up on CRF data entry, query status, and SAEs.

• Conduct on-site study-specific training (if applicable).

• Perform site facilities assessments

• Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution

Overall Accountabilities from Site Identification to Close out:

Ensure timely and accurate completion of project goals and update of applicable trial management systems.

• Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.

• Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.

• Ensure that assigned sites are audit and inspection ready

• Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.

• Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.

• Show commitment and perform consistent high quality work.

• Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.

• Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.

• Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.

• Provide input and feedback for Performance Development Conversation(s).

• Proactively keep manager informed about work progress and any issues.

• Develop expertise to become a subject matter expert.

• Work in a self-driven capacity, with limited need for oversight.

• Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Skills:

• Strong problem solving skills

• Able to take initiative and work independently, and to proactively seek guidance when necessary.

• Excellent presentation skills.

• Client focused approach to work.

• Ability to interact professionally within a client organization.

• Flexible attitude with respect to work assignments and new learning.

• Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.

• Strong ability to make appropriate decisions in ambiguous situations.

• Willingness to work in a matrix environment and to value the importance of teamwork.

• Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.

• Excellent interpersonal, verbal, and written communication skills.

• Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables.

• Excellent time management in order to meet study needs, team objectives, and department goals.

• Proven ability to work across cultures.

• Shows commitment to and performs consistently high quality work.

• Ability to successfully work in a ('virtual') team environment.

• Consulting Skills.

• Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.

• Act as a mentor and role model for other team members.

• Effectively enlist the support of team members in meeting goals.

• Attention to detail.

• Holds a driver's license where required.

Knowledge and Experience:

• Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology

Education:

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience