Clinical Research Assistant Resume Samples

Description :

1. Assisted with subject recruitment procedures and Maintained accurate and timely research records while maintaining patient confidentiality.
2. Performed task management and additional administrative responsibilities and identify any problems with protocol compliance.
3. Maintained all Regulatory Documents Protocol, IRB Site Application, Confidentiality Agreements, CV's of PI's and Sub-PI's, Medical Licenses, Informed Consent Forms, FDA form 1572.
4. Maintained site files and study documentation and status reports and document quality control.
5. Collected and maintain a file of regulatory documents, study documentation and communication for each study.
6. Administered research questionnaires to study participants, accurately and systematically collecting confidential information on drug use, hiv risk behaviors, and other sensitive information.
7. Entered and track data in study database Screened participants for eligibility and obtain informed consent for study participation Assisted in entering all pertinent data in computer system in timely manner as was outlined by department guidelines.
8. Assisted with scheduling consultations, diagnostic tests and procedures.

Experience

7-10 Years

Level

Management

Education

Bachelor's In Science

Description :

1. Coordinated up to ten GI/liver research studies, including industry clinical trials and registry studies, in a fast-paced and time-sensitive environment.
2. Screened research participants for eligibility; enrolled subjects with sponsor; interviewed patients in English, Spanish, and Korean.
3. Wrote informed consent forms in Institutional Review Board (IRB) standards and communicated research protocols to patients by translating technical knowledge into ordinary language.
4. Assisted with regulatory submissions (new applications, renewals, closed studies, amendments) to the IRB; collected and reported serious adverse events (SAEs) and protocol violations to research team, IRB, and sponsors.
5. Prepared weekly reports; scheduled and facilitated meetings with principal investigators, sponsors, and researchers; briefed to the Director on research progress and outcomes.
6. Performed scrupulous data collection, data entry, and data analysis using several types of Electronic Data Systems (EDCs) provided by study sponsors.
7. Devised solutions to quickly categorize missing data, reducing mistakes to 20 percent; resolved queries in timely manner.

Experience

10+ Years

Level

Senior

Education

MSc

Description :

1. Applied data from clinical research patients into numerous electronic databases within data entry guidelines, data validity checks, data conventions, query procedures, and data validation.
2. Assisted in transfer of data across platforms for other users, both internal and external to Clinical Affairs.
3. Created subject trackers and all data input for divisional internal/ external reviews for annual reports, publication support, and regulatory efforts using InfoPath and Excel programs.
4. Coordinated functions of different departments and employees who work for a clinical trial in investigating new health care medicines, technologies and procedures.
5. Supervised staff involved in the trial and ensured that protocol is maintained.
6. Extended research experience in Endocrinology, Hematology, Neurology and Urology.
7. Maintained an overall knowledge of applicable regulations, regulatory guidance documents, and industry standards toward each trial that our site participates in.
8. Reviewed each protocol thoroughly, and organized detailed accounts of which visits were pending with accurate and clean data.

Experience

2-5 Years

Level

Junior

Education

Bachelor Of Arts

Description :

1. Interviewed and screened patients for admission into Phase I through Phase III clinical trials.
2. Monitored patients for signs and symptoms of their condition during wash out of their medications, and then administered Investigational Product.
3. Observed and documented ongoing effects of study medications, Collected, processed and shipped out blood and urine samples, and updated and organized patient progress charts to report results to Sponsor/CRO/IRB.
4. Liaised with doctors/consultants or investigators on conducting the trial and verifying that data entered on to the CRFs were consistent with patient clinical notes, known as source data/document verification (SDV).
5. Organized, and/or maintained the study database, data entry, validation, and quality control of behavioral and lab data.
6. Conducted basic data processing and statistical analysis, finally worked with the CRA to update the Patient Tracking Database.
7. Trained new staff to follow protocol, document data and provide care to patients.

Experience

5-7 Years

Level

Executive

Education

MD In Medcine

Description :

1. Responsible for assisting with the initiation and management of various clinical research studies, site management and compliance monitoring of assigned clinical projects.
2. Participated in screening subjects for studies and conducted the consent process for eligible patients.
3. Monitored patients while recording and entering data in clinical research areas including Alzheimer's disease, diabetes, lipid management, GERD, male and female hormonal therapy, anxiety, depression, and osteoporosis.
4. Coordinated study visits in the appropriate window and ensured that the subjects received all necessary procedures and assessments.
5. Provided assistance in administering various research examinations including frailty, neurological assessments, MMSE, six-minute walk, and Quality of Life questionnaire.
6. Assessed adverse events throughout a subject's participation period and reported all necessary data to the sponsor's team.
7. Completed source documents and CRF's and maintained organized Subject binders.

Experience

2-5 Years

Level

Junior

Education

Biochemistry

Description :

1. Assisted the Principle Investigator and Site Director with the execution of multiple clinical trial protocols in accordance with federal, sponsor, and IRB guidelines and good clinical practice.
2. Documented all trial procedures and communication with subjects, study team members, sponsors, central laboratories, institutional review boards, and trial vendors.
3. Entered data into electronic data capture systems and responded to queries of such data as appropriate.
4. Collected, processed, and shipped blood and urine specimens and collected electrocardiograms and subject vitals.
5. Performed point-of-care urinalysis and pregnancy testing.
6. Reported safety issues or protocol deviations to the appropriate authorities.
7. Arranged daily laboratory testing materials according to protocol defined testing schedules and performed laboratory inventory, ordering, and quality assurance.
8. Dispensed study medication(s) and assessed subject drug accountability and medication inventories.

Experience

2-5 Years

Level

Junior

Education

Diploma

Description :

1. Maintain required records including case report forms, drug dispensation records, or regulatory forms.
2. Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
3. Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
4. Assess eligibility through screening interviews, reviews of medical records, and discussions with medical staff.
5. Identify protocol problems, assist in problem resolution efforts such as protocol revisions.
6. Prepare protocol worksheets, procedural manuals, adverse event reports, IRB documents, and progress reports.
7. Evaluate factors such as sample collection processes, data management plans, and potential subject risks.
8. Inform patients or caregivers about study aspects and outcomes to be expected.

Experience

7-10 Years

Level

Management

Education

Certificate In Nursing

Description :

1. Coordinate site management and monitoring support of all sponsored clinical studies.
2. Perform pre-study qualification, initiation, routine and close-out visits.
3. Resolve issues related to study monitoring with assistance of Clinical Research Nurse.
4. Maintain working knowledge of protocols for assigned clinical studies.
5. Possess the ability to identify, recommends as well as implements solutions to study issues.
6. Collect and ensure completeness of essential regulatory documentation for investigational studies in compliance with required guidelines.
7. Adhere to all standard operating procedures including site GCP and IRB compliance Oversees study activities including monitor visits, data collection and securing bio specimen management.
8. Responsible for overseeing quality assurance of study activities including quality of data.

Experience

2-5 Years

Level

Junior

Education

Business Administration

Description :

1. Coordinates the development, implementation and conducts multiple research trials.
2. Ensures compliance of research programs and associated research studies.
3. Performs administrative responsibilities, daily communication and operational issues/activities related to multiple research projects.
4. Reviews and screens objective and rationale of potential clinical trials.
5. Coordinates the execution of assigned protocols in accordance with research governing entities.
6. Develops training and educational material for assigned protocols and staff development.
7. Interacts with finance and legal teams to facilitate clinical trial budgets, site budgets and contract budgets.
8. Maintains professional relationships with Sponsors, CROs, FDA, IRBs, academic institutions and research networks/collaborations (national and international).

Experience

7-10 Years

Level

Management

Education

M.A. In Clinical

Description :

1. Receiving and processing authorizations and all requests for referrals and treatment authorizations.
2. Obtaining authorizations from various insurance carriers via phone, in writing or electronic media.
3. Scheduling appointments for specialty care, special studies or other ancillary services.
4. Coordinating care within the guidelines of multiple health plans, contracts or insurance types.
5. Responding to inquiries as to current status of authorization by assessing and evaluating the requests.
6. Initiating the appropriate documentation of requests from specialties offices for ongoing care.
7. Follows-up on missing documentation to obtain authorization or scheduling when appropriate.
8. Using various modules of the computer system to obtain information, schedule appointments and query information.

Experience

5-7 Years

Level

Executive

Education

Biology

Description :

1. Receive track and inventory documents for central files.
2. Ensure that documents required by team members are accessible.
3. Obtain any missing/incomplete data from investigators in conjunction with CRAs.
4. Ensure accuracy of coded documents for central files, perform document scanning when applicable.
5. Produce reliable up to date reports of patient/study status through maintaining CTMS or client equivalent to ensure that clinical data input is up to date, accurate and complete.
6. Ensure the complete documentation and timely arrival of clinical supplies and study drugs for site visits, in conjunction with CRAs.
7. Manage time, expenses and visit frequency per study guidelines.
8. Ensure CRF pages are being processed, tracked and forwarded to Data Management on time.

Experience

7-10 Years

Level

Management

Education

Business Administration

Description :

1. Coded all incoming paper documents for 5 research studies dealing with Alzheimer's and Dementia subjects.
2. Maintained Microsoft Excel spreadsheets on closed study materials for storage.
3. Created filing systems and policy and procedures for future research studies.
4. Responsible for designing and recording data entered into Microsoft access database.
5. Designed, and created Policy and Procedures manual using Microsoft Word for all data entry staff.
6. Responsible for training all incoming work study students for special data entry projects.
7. Coordinated development of data capture tools using Microsoft Access.
8. Data collection by a variety of approaches which included phone interviews, questionnaires or in person interviews following research protocols.

Experience

2-5 Years

Level

Junior

Education

Bachelor Of Science