Clinical Research Associate, Innova Solutions, Bethesda, MD
Innova Solutions -
Bethesda, MD,
US
Clinical Research Associate
Date Posted: 2024-06-11
Job description
Innova Solutions is immediately hiring *Clinical Research Associate**.*
*Position type: Fulltime - Contract *
*Duration: 12 Months*
*Location: Bethesda, MD*
As *Clinical Research Associate, *you will:
*Job Description:*
* *
*Bethesda, MD area (candidates in DC and Northern, VA will also be considered). *
*Summary: *
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 interim and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.
This is a contract traveling CRA position if necessary.
*Primary responsibilities for role: *
* Has a solid knowledge of the therapeutic area or a therapeutic background showing has adeptness to work in oncology and phase 1 studies
* Performs regulatory document review and monitors adherence to the regulatory document collection process.
* Able to write clinical monitoring plan, source documents and create other study tools when requested.
* Conducts monitoring/co-monitoring activities for interim site monitoring and closeout visits, in conformance to all relevant laws, regulations, guidelines, protocol, and internal SOPs/policies.
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.
* 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. * Collaborates with data management to resolve queries.
* 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.
* Understands and implements processes for distribution and tracking of SAEs, safety documentation, and pregnancies. Monitors compliance of these processes.
* Facilitates investigator site payments, as applicable.
* Reviews/creates/tracks trial newsletters, memos, mass correspondence or other appropriate trial-related documentation.
* Obtains a complete understanding of all trial-related documents and operational procedures.
* Maintains clinical trial tracking information pertaining to the study e.g. Monitoring calendar, Monitoring reports, phone contacts.
* Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
* Reviews and tracks study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
* Communicates and interacts 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.
* Prepares key reports and documents on progress of study for study manager.
* Tracks study specific tasks and progress of the trial.
* Reviews study and/or site specific ICF(s) for compliance with ICH/GCP and company SOPs.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
Managers and supervisors may assign other duties as needed.
*Knowledge, Skills and Abilities:*
* Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
* Good knowledge of therapeutic area assigned; oncology
Preferred experience working with NCI * Strong knowledge of ICH/GCP Guidelines and EDC process.
* Ability to establish rapport with site personnel/ colleague.
*Thank you!*
*Pradip Joshi*
*Senior Associate, Recruitment *
*Phone: *
*213-###-####*
* *
*PAY RANGE AND BENEFITS:*
*Pay Range*:* $90-$95/Hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
* *
*Benefits:* Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
*ABOUT INNOVA SOLUTIONS:* Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
* *
*Recent Recognitions: *
* *
* One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
* ClearlyRated Client Diamond Award Winner (2020)
* One of the Largest Certified MBE Companies in the NMSDC Network (2022)
* Advanced Tier Services partner with AWS and Gold with MS
*Website*:
[
*Innova Solutions* is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or
(770) ###-####
. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.
*Position type: Fulltime - Contract *
*Duration: 12 Months*
*Location: Bethesda, MD*
As *Clinical Research Associate, *you will:
*Job Description:*
* *
*Bethesda, MD area (candidates in DC and Northern, VA will also be considered). *
*Summary: *
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 interim and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study.
This is a contract traveling CRA position if necessary.
*Primary responsibilities for role: *
* Has a solid knowledge of the therapeutic area or a therapeutic background showing has adeptness to work in oncology and phase 1 studies
* Performs regulatory document review and monitors adherence to the regulatory document collection process.
* Able to write clinical monitoring plan, source documents and create other study tools when requested.
* Conducts monitoring/co-monitoring activities for interim site monitoring and closeout visits, in conformance to all relevant laws, regulations, guidelines, protocol, and internal SOPs/policies.
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.
* 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. * Collaborates with data management to resolve queries.
* 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.
* Understands and implements processes for distribution and tracking of SAEs, safety documentation, and pregnancies. Monitors compliance of these processes.
* Facilitates investigator site payments, as applicable.
* Reviews/creates/tracks trial newsletters, memos, mass correspondence or other appropriate trial-related documentation.
* Obtains a complete understanding of all trial-related documents and operational procedures.
* Maintains clinical trial tracking information pertaining to the study e.g. Monitoring calendar, Monitoring reports, phone contacts.
* Assists with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation).
* Reviews and tracks study documents, including: project files both electronically and in the Trial Master File and Project Status Reports.
* Communicates and interacts 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.
* Prepares key reports and documents on progress of study for study manager.
* Tracks study specific tasks and progress of the trial.
* Reviews study and/or site specific ICF(s) for compliance with ICH/GCP and company SOPs.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
Managers and supervisors may assign other duties as needed.
*Knowledge, Skills and Abilities:*
* Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.
* Good knowledge of therapeutic area assigned; oncology
Preferred experience working with NCI * Strong knowledge of ICH/GCP Guidelines and EDC process.
* Ability to establish rapport with site personnel/ colleague.
*Thank you!*
*Pradip Joshi*
*Senior Associate, Recruitment *
*Phone: *
*213-###-####*
* *
*PAY RANGE AND BENEFITS:*
*Pay Range*:* $90-$95/Hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
* *
*Benefits:* Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
*ABOUT INNOVA SOLUTIONS:* Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
* *
*Recent Recognitions: *
* *
* One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
* ClearlyRated Client Diamond Award Winner (2020)
* One of the Largest Certified MBE Companies in the NMSDC Network (2022)
* Advanced Tier Services partner with AWS and Gold with MS
*Website*:
[
*Innova Solutions* is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or
(770) ###-####
. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b.The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.
American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.