Clinical Research Coordinator - Bethesda, United States - Dovel Technologies

Description

Clinical Research Coordinator page is loaded

Clinical Research Coordinator

Apply

locations

US - MD, Bethesda

time type

Full time

posted on

Posted 6 Days Ago

job requisition id

18581


Job Family :
Patient Care Coordinator (Digital)

Travel Required :
None

Clearance Required :
Ability to Obtain Public Trust


What You Will Do :
We are currently searching for a

Clinical Research Coordinator

to

provide

clinical research coordination

and protocol navigation for the NINDS Intramural Research Program

.

This is a full-time, on-site opportunity in

Bethesda,


MD
.
Participate in coordination and management of most daily activities of the study and ensure that study activities follow

established protocol, Standard Operating Procedures (SOP), and

utilizes

approved forms,

templates,

and practices.

Prepare and

submit

accurate

source documents related to all research procedures

for review

.

Prepare and

submit

Case Report Forms (CRFs) and document changes in research participant condition, adverse

events, concomitant medication use, protocol compliance, response to study

drug, and other required fields.

Enter data into research databases,

systems,

and applications for ongoing studies.

Assist

researchers with study testing, observations data entry and other duties associated with study sessions.

Assist

researchers in collecting, organizing, and

maintaining

accurate

records of all protocols and study applications,

investigator qualifications, study logs, safety reports, annual reports, and correspondence.

Work with staff on the design, development

,

and preparation of documents such as

CRFs,

spreadsheets, letters, rosters,

agendas, presentations

,

and meeting minutes/summaries.

Retrieve research related information from medical records, hospital information system and laboratory information

system and create spreadsheets and other reports for use in study analysis.

Adhere to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research

including biospecimen handling shipment.

Assist

protocol staff

submit

initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse

Events, protocol deviations, and Safety Letters

in accordance with

local and federal guidelines.

Work with investigators to

a

ssist

researchers

submit

protocol packages, actions and applications to
IRBusing the

designated protocol tracking and management databases system.

Assist

staff on all

facets

of clinical studies including subject enrollment, scheduling outpatient appointments and

inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample

collection and data entry.

Document, collect, record, and

retain

all research related participant encounters including in person, phone, or

electronic in the research record

e.g.,

source documents, case report forms according to regulations, guidelines, and

institutional specific policies, including ensuring good documentation practices for all documents.

Instruct data entry and clinical staff in procedures

relative

to data management, protocol instructions, Standard

Operating Procedures and regulatory processes and considerations.

Research changes and updates to Good Clinical Practices (GCP) and prepare summaries, job aids and training

materials for research staff and new clinical research coordinators.


What You Will Need :
Bachelor's

d

egree

At least 4

years of

clinical research

experience

.

Experience with

electronic systems such as

Clinical Trial Management System (CTMS)

,

Electronic

Medical

R

ecords System

, or

Electronic Data Capture System

What Would Be Nice To Have :
Professional certification highly desired

specifically from one of the following organizations

Association of Clinical Research Professionals Certified

Professional (ACRP-CP)

;

Association of Clinical Research

Professionals (ACRP)

;

Certified Clinical Research

Professional (CCRP)

;

Certified Clinical Research Coordinator

(CCRC)

;

Certified Clinical Research Associate (CCRA)

.

Oversee and document IP dispensing,

inventory,

and

reconciliation

.

Clos

e

clinical trial sites down on completion of

clinical trial

.

Order tracking, managing IP and trial materials

.

Implementation of clinical trial site action plans

.

Train clinical

trial site staff

.

Coordinat

e

project meetings

and

monitor

remote sites

.

Previous

clinical

research or

trial work

, specifically Phase I or II experience

.

Electronic medical records

.

Protocol

development,

review

,

revision

,

and navigation

.

Maintain p

atient confidentiality

and

r

egulatory compliance

.

Data

Monitoring

and I

ntegrity

.

Recruitment

,

s

cheduling

,

and s

creening

of study participants

.

Liais

e

with regulatory authorities

and the

ethic

committee

.

Oversee r

egulatory affairs

and


IRB
submissions.


What We Offer:

Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.

Benefits include:
Medical, Rx, Dental & Vision Insurance

Personal and Family Sick Time & Company Paid Holidays

Parental Leave

401(k) Retirement Plan

Group Term Life and Travel Assistance

Voluntary Life and AD&D Insurance

Health Savings Account, Health Care & Dependent Care Flexible Spending Accounts

Transit and Parking Commuter Benefits

Short-Term & Long-Term Disability

Tuition Reimbursement, Personal Development, Certifications & Learning Opportunities

Employee Referral Program

Corporate Sponsored Events & Community Outreach

annual membership

Employee Assistance Program

Supplemental Benefits via Corestream (Critical Care, Hospital Indemnity, Accident Insurance, Legal Assistance and ID theft protection, etc.)

Position may be eligible for a discretionary variable incentive bonus

About Guidehouse
Guidehouse is an Equal Employment Opportunity / Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.

If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at or via email at

. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies.

All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee.

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