Clinical Research Associate Resume Samples

Description :

1. Provides site management and monitoring support for sponsored clinical studies.
2. Conduct Site Qualification, initiation visits, on-site monitoring visits, co-monitoring visits, and site closure visits of all phases of clinical trials Prepare site visit reports and provide assistance to site staff in resolving deficiencies.
3. Educates and trains site and study staff in conduct and management of sponsored studies, including assurance to regulatory and ICH/ GCP compliance.
4. Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
5. Assist in the protocol, Informed Consent, and CRF design and review.
6. Develops and demonstrate an understanding of and apply therapeutic area knowledge to assignments and project-related issues.
7. Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.

Experience

7-10 Years

Level

Management

Education

BSc In Management

Description :

1. Assisted the data management groups and the project team in the processing of all clinical data by ensuring the timely collection of other aspects of job-related responsibilities data and query resolution.
2. Conducted site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
3. Coordinated with investigators and site workers to ensure that the protocol is being adhered to while checking for Protocol deviations throughout the course of the study.
4. Developed recruitment strategies and an enrollment plan with the investigator and site staff to meet recruitment goals in coordination with the SOP and GCP guidelines.
5. Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials.
6. Ensure Visit Reports are written and submitted via CTMS within 5 working days of visit.
7. Participate in various sponsor/project team communication and training sessions Prepares for and attends Investigator Meetings Responsible for the evaluation of clinical data to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH/GCP Guidelines.
8. Worked as an integral team member with respect to quality, integrity, timeliness, and cost effectiveness when monitoring Worked in conjunction with the in-house project teams to ensure that sites have adequate study drugs and supplies.

Experience

2-5 Years

Level

Executive

Education

Bachelor Of Science

Description :

1. Responsible for the start-up, initiation, implementation and the management of clinical trials for the assigned sites.
2. Monitor and provide site management oversight for assigned clinical trials (phase I- IV) according to ICH-GCP guidelines, FDA regulations, protocol and sponsor SOPs.
3. Collaborate closely with the entire study team, including the medical Monitor, Project Manager, and the entire in-house study team to ensure the successful execution of the clinical study.
4. Independently prepare and perform Investigator site visits relevant to the phase of the study including, site selection and qualification, initiation, regular monitoring or site closure visits as specified in the Project Plan and the Monitoring Guidelines.
5. Ensure compliance of the trial conduct with the protocol and the applicable guidelines and regulations.
6. Report any findings related to the study to the Project Managers responsible for the respective studies.
7. Review patient documents (informed consent, subject information sheet), clinical study protocol, CRF and trial related financial agreements as required to ensure compliance with the protocol and study guidelines.
8. Ensure that Serious Adverse Events, IND Safety Alerts, Protocol Deviations and other safety related items are reported to the IRB to ensure that the subject's rights, safety and well-being are protected.

Experience

2-5 Years

Level

Junior

Education

Doctor Of Medicine

Description :

1. Managed startup and completion of activities associated with clinical research studies per CFR and ICH regulations and ISO requirements.
2. Assisted in preparation of final study reports, statistical analysis plans, data management plans and other required reports leading to FDA approval and job promotion.
3. Created, maintained and managed Trial Master Files for compliance Managed clinical project functions through weekly project team meetings, study performance metrics creation, review and management.
4. Assisted in managing financial aspects of the project including CRO, vendor and site payments, tracking and processing of payments.
5. Monitored and managed study sites, ensuring site's completion of regulatory activities and integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
6. Enforced and ensured adherence to GCPs of all clinical sites.
7. Participated in design and coordination of pre-clinical development projects, leading to future clinical trials and subsequent approval of new products.
8. Evaluated and analyzed clinical studies in conjunction with Regulatory Affairs and Research and Development, resulting in design of new protocols and start of new clinical trials.

Experience

10+ Years

Level

Senior

Education

Developmental Biology

Description :

1. Assisted with development, management, site monitoring and implementation of clinical, behavioral and pharmaceutical trials while managing over 15 domestic and international sites in the NIH-funded HIV Prevention Trials Network.
2. Primary Clinical Study: HPTN 064 The Women's HIV Seroincidnece Study Site management and site monitoring of ten clinical research sites via outbound telephone calls, web-based tools, and other communications tools to ensure compliance with the protocol requirements, study procedures and ICH/GCP/EMEA/FDA guidelines.
3. Performed site activities including site initiation, sites selection, site/study monitoring and site/study closeout visits.
4. Managed qualitative data and performed qualitative analysis using Nvivo 8.
5. Assisted with writing manuscripts for journal submissions and abstracts for professional conferences.
6. Monitored regulatory reviews including IRB, and participated in protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance.
7. Conducted literature reviews for manuscript planning and conducted orientation of additional qualitative staff.
8. Developed study training materials and facilitated trainings with study team and sites as needed.

Experience

7-10 Years

Level

Management

Education

Master In Public Health

Description :

1. Coordinate with the collection, distribution, and storage of data obtained during clinical research trials, for the testing of drugs and medical products.
   
2. Ensured that trials stay on track with clinical objectives and complies with federal regulations, analyze data, create comprehensive reports, make presentations and monitor individual cases.
3. Performed CRF review; query generation and resolution against established data review guidelines data management systems.
4. Ensure study staff conducting the protocol have received the proper materials, instructions, and training to safely enter subjects into the study and complete the protocol requirements, as written.
5. Identified and completed follow-up of Serious Adverse Events at assigned study sites.
6. Ensured the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
7. Ensure that the Site Regulatory Documents are complete and current through trial.

Experience

7-10 Years

Level

Management

Education

AAS In Nursing

Description :

1. Responsible for all aspects of site management from site selection to site close out.
2. Involved in the investigator site identification process and performed site evaluation visits to ascertain site's capabilities and suitability to conduct the clinical trial.
3. Site study start up activities including budgeting, contract development and negotiations, site initiation visits, and GCP Instruction to Investigators/Research Personnel.
4. Managed the site regulatory submission process to ensure that all bottlenecks are ironed out and that delay of the clinical trial campaign is avoided.
5. Conducted presentations and trained site personnel during Investigator Meetings.
6. Performed ongoing site monitoring visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication.
7. Performed troubleshooting and problem solving tasks at sites to help achieve turnaround results.
8. Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists as required during the study.

Experience

2-5 Years

Level

Junior

Education

B.S In Public Health

Description :

1. Conducted routine monitoring and close-out visits at Investigative sites to assess protocol, regulatory and ICH-GCP compliance.
2. Carried out site-initiation visits and ensured that all study materials such as updated protocols, investigator brochures, instructions and investigational product is received by the site.
3. Trained the investigator and staff regarding Study protocol and conduct via presentations, informational handouts and group discussions, identified any study related issue and suggested corrective measures if any or escalated the issue to the Manager as needed.
4. Ensured the subject enrollment, advertising for the study, ICF process, reviewed EDC against source data such as patient diaries, laboratory results, scans etc.
5. Ensured all the essential documents are maintained in the investigator site folder and is updated with new or amended documents and essential documents are forwarded to the sponsor for updating the TMF as necessary.
6. Assured timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs).
7. Documented all findings and activities at the site and complete a monitoring visit report and submit to the Manager.

Experience

2-5 Years

Level

Executive

Education

Microbiology

Description :

1. Responsible for reviewing and tracking of study essential documents (e.g., IRB approvals, 1572s, CVs, investigator licenses and board certifications, lab certifications and normal ranges, etc) to ensure completeness and accuracy.
2. Verify and ensure proper storage/handling, accountability and distribution of investigational product and trial supplies.
3. Review and track regulatory documents and the verification of data management queries to meet clinical study timelines.
4. Monitor clinical studies in accordance with sponsor's protocol and GCPs to assess the safety and efficiency of investigational products.
5. Applying FDA regulations and ICH-GCP guidelines to all aspects of clinical studies including but not limited to: protocol compliance, IRB submissions, ICF review, handling adverse events to ensure safety and protection of study participants and enhanced data credibility.
6. Track and monitor enrollment at sites, initiating additional recruitment and retention strategies as required.
7. Manage time effectively in order to fulfill requirement to meet all timelines, in both therapeutic work and submission of administrative documents.

Experience

5-7 Years

Level

Executive

Education

Biological Science

Description :

1. Participate in site pre-study, initiation, routine monitoring, and study closeout visits in-line with SOPs and Protocols.
2. Compile reports to quality standards within company specified timelines.
3. Provide quality overview and consistency check on all developed ICFs and completes the informed consent checklist.
4. Conducting monitoring visits as needed, to assert protocol adherence; conduct source verification; verify drug accountability and storage requirements; and ensure compliance with regulatory requirements and SAE/AE reporting requirements.
5. Collect, review, track, and ensure appropriate completion of site-specific study/essential documents.
6. Performs ongoing reconciliation of the Trial Master Files (TMF) content to site files.
7. Creating, maintaining, and reviewing monitoring standard operating procedures, monitoring tools for conducting monitoring tasks including: monitoring plans, monitoring reports, corrective and preventive action plans.
8. Conduct training for investigative site personnel on study protocols and visit procedures Acts as primary liaison for assigned study sites while to convey project information.

Experience

10+ Years

Level

Senior

Education

Bachelor's In Economics

Description :

1. Conduct monitoring visits to perform on-site review of files and records for source document verification and review of case report forms for completeness, accuracy, consistency and Protocol compliance.
2. Perform drug accountability to ensure adequate storage, dispensing and use of investigational product at the site.
3. Conduct pre-study visits to evaluate the suitability of investigational sites for the investigation study and ensured the availability of facilities, resources, and qualified and experienced personnel.
4. Review Serious Adverse Event (SAE) reports and ensured that appropriate reporting procedures were performed within the required time frame.
5. provide on-going instruction to research site personnel, as necessary, on proper conduct of the trial.
6. Perform routine monitoring visits according to the monitoring plan to ensure site adherence to protocol and all study guidelines.
7. Conduct initiation visits to open up investigational sites for clinical studies and ensured the investigational product has been received and that all study supplies and equipment have been received and ready for the commencement of the study.

Experience

2-5 Years

Level

Junior

Education

Masters Of Science

Description :

1. Travel performing on-site monitoring visits, including site selection, site initiation, periodic, close out and corrective action visits.
2. Independently performs monitoring activities for multiple sites and multiple projects, identifying deviations from regulations and SOPs.
3. Evaluates protocol and regulatory compliance, including source document verification, informed consent process, human subject protection, data integrity, drug accountability, compliance, review of investigator and regulatory files.
4. Provides study training and guidance to designated site personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations.
5. Identify action items, subject safety, data integrity issues and retrain site personnel accordingly.
6. Communicates routine and unusual findings to trial supervisor.
7. Independently documents routine site management and ongoing follow-up, clinical monitoring activities, site communication and trial related activities.
8. Provides knowledge of protocol, study documents and processes, during monitoring activities.

Experience

10+ Years

Level

Senior

Education

Bachelor Of Science