Clinical Research Specialist Job Description
Clinical research specialist
provides financial, administrative, and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations, and SOPs.
Clinical Research Specialist Duties & Responsibilities
To write an effective clinical research specialist job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical research specialist job description templates that you can modify and use.
Sample responsibilities for this position include:
Independently monitor clinical studies in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines and SOPs, utilizing knowledge of the diagnostic area sufficient to perform source data verification and monitor study protocol conduct / compliance
Ensure study activities are performed in compliance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and Good Laboratory Practices (GLPs) regulations
Reviewing and negotiating non-clinical (legal) sections of the Initial and Amendment ICFs
Confirming language used in IRB Approved ICFs is acceptable and can be utilized for Amended ICFs
Working with central IRBs to negotiate standard template language in the ICF
Interfacing with research centers
Maintaining an electronic ICF repository, including tracking of ICFs into an Access Database
Conduct study site file maintenance reviews
Ensure ongoing regulatory compliance with clinical research activities and documentation
Assist in the development of study manual of operations and procedures for clinical research studies
Clinical Research Specialist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Clinical Research Specialist
List any licenses or certifications required by the position: CCRA, CDE, CITI, AHA, BPS, CRC, BLS, ACRP, CPR, CFDA
Education for Clinical Research Specialist
Typically a job would require a certain level of education.
Employers hiring for the clinical research specialist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Health, Science, Allied Health, Education, Associates, Nursing, Medical, Psychology, Biology, Performance
Skills for Clinical Research Specialist
Desired skills for clinical research specialist include:
Medical terminology
Good Clinical Practice and regulatory compliance guidelines for clinical trials
Biologics
For devices
Global clinical regulations
Good Clinical Practices
Pharmaceuticals
GCP
Good Clinical Practice and regulatory compliance guidelines for conducting clinical studies
Applicable disease states
Desired experience for clinical research specialist includes:
Create training media and documentation for on-site and in-house study personnel
Communicate actively with various departments involved in each study including sponsors, investigators, quantitative sciences unit, and the Stanford IRB to ensure timely completion of project milestones
Extensive review of Trial Master File and Site Files to ensure files are complete, accurate and compliant with ISO14155, applicable FDA Code of Federal Regulations, project plans and internal SOPs
Critical review of target records, to identify any audit risks
Document file review, all findings and actions as a deliverable to the Clinical Trial Manager
Adhere to the protocols’ Data Safety Monitoring Plans
Clinical Research Specialist Examples
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Clinical Research Specialist Job Description
Job Description Example
Our company is hiring for a clinical research specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical research specialist
- Participate in the evaluation of research protocols including study design and risk to target population
- Participate in protocol development and budget development as needed
- Schedule and/or coordinate study-related meetings, training sessions and pre-study site visits of sponsors
- Order and receive drug/device supplies for studies and maintain appropriate inventory
- Conduct study-related and clinical-related assessments
- Construct and maintain databases
- Provide/create source documentation tools for subject’s charts/records
- Conduct weekly meeting with investigators
- Recruitment for open clinical trials
- Maintain IUPDP Subject Registry
Qualifications for clinical research specialist
- Accuracy, dependability, and good interpersonal communication skills
- Presents a professional manner and appearance
- A positive, flexible attitude and the ability to work effectively with cross functional teams
- Able to lift 50lbs and wear protective lead aprons
- Compliance oversight for clinical trials
- Assist in the preparation of study documents including IRB application, SOPs and Informed Consent
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Clinical Research Specialist Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of clinical research specialist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for clinical research specialist
- Will assist in soliciting industry-sponsored trials through contacts and professional organizations
- Compose and supervise preparation or modification of regulatory documents including updates to Informed Consent forms submitted to IRB
- Works closely with study site personnel to resolve issues, payments, supplies, enrollment/randomizations, product accountability
- Plays an active role as trainer for purposes of cross-training or for educating new PSM employees
- Conduct clinical trials in the section of Hematology/Oncology
- Ensure compliance with study schedules and data submission
- Prepare/submit institutional review board documents and regulatory documents for sponsors
- Audit internal documents for accuracy and compliance with good clinical practice
- Prepare and submit Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary)
- Schedule study-related meetings and training sessions
Qualifications for clinical research specialist
- 7+ years experience supporting clinical research
- Demonstrated ability to perform systemic analysis and make timely and well-reasoned decisions based on an insightful analysis of all critical information and the pros and cons of alternatives
- Demonstrated ability to effectively and persuasively communicate verbally and in writing
- Able to travel up to 25% and at the direction of the Manager
- Experience facilitating committees
- Demonstrated ability to motivate and hold individuals accountable to deliverables
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Clinical Research Specialist Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of clinical research specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research specialist
- Works with appropriate parties and reviews all quarterly and annual proposed and final federal rules for assigned programs
- Actively participates in the communication of the Compliance program
- Review patient narratives and comment as needed where he/she sees possible errors or missing information
- Under supervision of Clinical Affairs Sr
- Remains current with regulatory requirements for in vitro diagnostic products
- Completes all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical trials including collection, timely review and analysis of data generated
- Schedules and completes on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data
- Communicates with study investigators via phone, fax, email and/or letters regarding activities in all phases of the study
- Coordinates with biostatisticians and data managers to manage incoming clinical site data, design/maintain databases, and ensure integrity of the database
- Provides up-to-date clinical study progress reports
Qualifications for clinical research specialist
- Bachelor’s or Master’s degree in Biosciences, Nursing, Pharmaceutics, or equivalent field
- 2~3 years of experience at clinical research in medical device or related industry
- CCRA is basic requirement
- Travel up to 30% (within Singapore)
- Scientifically minded
- At least 1 year in a CR&D capacity performing data review in oncology/hematology
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Clinical Research Specialist Job Description
Job Description Example
Our growing company is looking to fill the role of clinical research specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research specialist
- Represents Clinical Affairs on multifunctional team tasked with preparing responses to regulatory agencies
- Represents Clinical Affairs on multifunctional team tasked with the preparation of scientific abstracts, posters, and publications reporting results of the clinical studies
- Coordinate studies from startup through close-out by assisting with site startup activities for multiple sites and performing site management activities throughout the study period and closeout
- Assist in developing recruitment strategies and recruitment aids such as brochures and flyers
- Manage research project databases in conjunction with the study data managers, develop site flow sheets and other study related documents, and follow up with study sites to ensure completion of study documents/case report forms
- Assemble and ship study kits for study sites, ensure sites recruit participants and schedule procedures according to the study protocol
- Track tasks and deliverables and invoice components of the study budget
- Review and provide input on patient recruitment and retention plans
- Collaborate with Clinical Data Management, Statistics, and Clinical Operations to create CRF guidelines/instructions
- Perform clinical research data management and completion of case report forms
Qualifications for clinical research specialist
- Experience/ability to use PC/Microsoft Windows software applications
- Experience working on oncology or hematology clinical trials
- Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data
- Familiarity with INFORM, RAVE, J-review or other clinical databases or other data review tools (patient profiles, listings) would demonstrate the candidate's familiarity with the scope of work
- Some experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative
- Ability to communicate medical or clinical information to a physician
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Clinical Research Specialist Job Description
Job Description Example
Our company is hiring for a clinical research specialist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for clinical research specialist
- Organize and attend monthly pediatric surgery research meeting with residents and faculty
- Organize study supplies
- Perform study preparation activities including but not limited to organizing internal and/or external facing prestudy meetings, assist in identifying supply needs, and developing and implementing Study Specific Procedures (as appropriate)
- Assist in the resource schedule determination of all study related activities
- Regularly communicate with Sponsor representatives
- Review Sponsor supplied study documents
- Manage and coordinate project timelines, resource coordination, and prioritization of assigned studies in conjunction with laboratory operations management and/or assigned lead analyst
- Prepare and submit Institutional Review Board documents
- Oversee subject recruitment and study enrollment goals for all sites
- Audit operations, to ensure compliance with applicable regulations
Qualifications for clinical research specialist
- Ability to understand clinical trial publications
- Candidate should have direct experience working on clinical trials from a sponsor's perspective
- Coordinate, conduct, and monitor four interventional study arms in an online classroom environment with a group of 4-6 participants
- Demonstration of strong writing skills in all job responsibilities
- Meticulous organizational and attention to detail skills
- Flexible, able to multi-task and prioritize work