Clinical Research Coordinator

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 assist researchers submit protocol packages, actions and applications to IRB using 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 degree

• At least 4 years of clinical research experience.

• Experience with electronic systems such as Clinical Trial Management System (CTMS), Electronic Medical Records 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.

• Close 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.

• Coordinate 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 patient confidentiality and regulatory compliance.

• Data Monitoring and Integrity.

• Recruitment, scheduling, and screening of study participants.

• Liaise with regulatory authorities and the ethic committee.

• Oversee regulatory 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

• Care.com 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 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. 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.